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Oral Tissue Tolerance of a Mouthrinse

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ClinicalTrials.gov Identifier: NCT01009554
Recruitment Status : Completed
First Posted : November 6, 2009
Results First Posted : July 3, 2015
Last Update Posted : July 3, 2015
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Basic Science
Condition Dental Health
Interventions Device: Potassium Oxylate Mouthwash
Drug: Sodium Fluoride Dentifrice
Enrollment 96
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description Crest® Cavity Protection Regular Toothpaste (Brushing Only) Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Period Title: Overall Study
Started 48 48
Completed 46 41
Not Completed 2 7
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             1             3
Noncompliant with Study Product             0             3
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) Total
Hide Arm/Group Description Crest® Cavity Protection Regular Toothpaste (Brushing Only) Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse) Total of all reporting groups
Overall Number of Baseline Participants 48 48 96
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 48 participants 96 participants
47.6  (9.96) 49.8  (8.08) 48.7  (9.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 48 participants 96 participants
Female
40
  83.3%
40
  83.3%
80
  83.3%
Male
8
  16.7%
8
  16.7%
16
  16.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
USA Number Analyzed 48 participants 48 participants 96 participants
48 48 96
1.Primary Outcome
Title Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment
Hide Description The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.909  (0.0612) 1.035  (0.0650)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.168
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.126
Confidence Interval (2-Sided) 95%
-0.054 to 0.306
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0905
Estimation Comments [Not Specified]
2.Primary Outcome
Title Oral Tissue Tolerance
Hide Description Oral tissue tolerance was assessed by oral tissue adverse events for which the relationship to treatment was considered as possible, probable, or very likely. If the relationship to treatment was missing, the adverse event was categorized as a treatment-related adverse event.
Time Frame through 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Safety Analysis Set, defined as all participants who used at least one dose of investigational product.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 48 48
Measure Type: Number
Unit of Measure: percentage of participants
Participants with ≥ one treatment-related AE 2.1 0.0
Sensitivity of teeth 2.1 0.0
3.Secondary Outcome
Title Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment
Hide Description The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.875  (0.0464) 0.882  (0.0475)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.928
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.006
Confidence Interval (2-Sided) 95%
-0.127 to 0.139
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0670
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment
Hide Description The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.805  (0.0496) 1.040  (0.0507)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.235
Confidence Interval (2-Sided) 95%
0.092 to 0.378
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0718
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment
Hide Description The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.013  (0.0857) 0.054  (0.0876)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.741
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.041
Confidence Interval (2-Sided) 95%
-0.205 to 0.286
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1235
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment
Hide Description The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.071  (0.0959) -0.090  (0.0981)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.249
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.161
Confidence Interval (2-Sided) 95%
-0.437 to 0.115
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1386
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment
Hide Description The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.158  (0.0949) -0.043  (0.1006)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.154
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.201
Confidence Interval (2-Sided) 95%
-0.479 to 0.077
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1398
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment
Hide Description The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.077  (0.0518) -0.117  (0.0529)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.195
Confidence Interval (2-Sided) 95%
-0.343 to -0.047
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0746
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment
Hide Description The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.123  (0.0487) -0.212  (0.0498)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.334
Confidence Interval (2-Sided) 95%
-0.474 to -0.195
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0703
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment
Hide Description The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.107  (0.0639) -0.107  (0.0677)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.214
Confidence Interval (2-Sided) 95%
-0.401 to -0.027
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0939
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Mean Stain Score Over All Tooth Sites at 4 Weeks
Hide Description The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.329  (0.0464) 0.386  (0.0505)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.319
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.056
Confidence Interval (2-Sided) 95%
-0.055 to 0.168
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0562
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Mean Stain Score Over All Tooth Sites at 6 Weeks
Hide Description The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.349  (0.0565) 0.621  (0.0605)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.272
Confidence Interval (2-Sided) 95%
0.139 to 0.405
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0668
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Mean Stain Score Over All Tooth Sites at 8 Weeks
Hide Description The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.394  (0.0703) 0.791  (0.0785)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.398
Confidence Interval (2-Sided) 95%
0.231 to 0.565
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0840
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Mean Stain Intensity Over All Tooth Sites at 4 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.154  (0.0224) 0.184  (0.0243)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.270
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.030
Confidence Interval (2-Sided) 95%
-0.024 to 0.084
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0271
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Mean Stain Intensity Over All Tooth Sites at 6 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.164  (0.0274) 0.302  (0.0293)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.137
Confidence Interval (2-Sided) 95%
0.073 to 0.202
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0324
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Mean Stain Intensity Over All Tooth Sites at 8 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.181  (0.0334) 0.375  (0.0372)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.193
Confidence Interval (2-Sided) 95%
0.114 to 0.273
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0399
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Mean Stain Area Over All Tooth Sites at 4 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.162  (0.0225) 0.196  (0.0245)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.217
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.034
Confidence Interval (2-Sided) 95%
-0.020 to 0.088
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0273
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Mean Stain Area Over All Tooth Sites at 6 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.166  (0.0270) 0.303  (0.0290)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.137
Confidence Interval (2-Sided) 95%
0.073 to 0.200
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0320
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Mean Stain Area Over All Tooth Sites at 8 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.188  (0.0340) 0.383  (0.0379)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.195
Confidence Interval (2-Sided) 95%
0.114 to 0.276
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0406
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks
Hide Description The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.408  (0.0590) 0.463  (0.0643)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.444
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain area score for interproximal (mesial and distal) sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.055
Confidence Interval (2-Sided) 95%
-0.087 to 0.197
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0716
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks
Hide Description The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.427  (0.0712) 0.776  (0.0762)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain score for interproximal (mesial and distal) sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.349
Confidence Interval (2-Sided) 95%
0.182 to 0.517
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0843
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks
Hide Description The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.451  (0.0889) 0.994  (0.0991)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain score for interproximal (mesial and distal) sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.542
Confidence Interval (2-Sided) 95%
0.331 to 0.754
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1063
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.192  (0.0284) 0.224  (0.0309)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.361
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.032
Confidence Interval (2-Sided) 95%
-0.037 to 0.100
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0344
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.205  (0.0350) 0.379  (0.0374)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.174
Confidence Interval (2-Sided) 95%
0.092 to 0.256
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0414
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.210  (0.0422) 0.475  (0.0470)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.264
Confidence Interval (2-Sided) 95%
0.164 to 0.364
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0504
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.202  (0.0284) 0.236  (0.0309)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.331
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.034
Confidence Interval (2-Sided) 95%
-0.035 to 0.102
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0345
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.206  (0.0348) 0.383  (0.0373)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.177
Confidence Interval (2-Sided) 95%
0.095 to 0.259
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0414
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.218  (0.0433) 0.483  (0.0483)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.265
Confidence Interval (2-Sided) 95%
0.162 to 0.368
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0519
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Mean Stain Score for Gingival Sites at 4 Weeks
Hide Description The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.383  (0.0596) 0.521  (0.0652)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.060
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.138
Confidence Interval (2-Sided) 95%
-0.006 to 0.282
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0726
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Mean Stain Score for Gingival Sites at 6 Weeks
Hide Description The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.395  (0.0732) 0.732  (0.0786)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.338
Confidence Interval (2-Sided) 95%
0.165 to 0.510
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0870
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Mean Stain Score for Gingival Sites at 8 Weeks
Hide Description The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.526  (0.0914) 0.920  (0.1023)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.394
Confidence Interval (2-Sided) 95%
0.176 to 0.612
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1095
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Mean Stain Intensity for Gingival Sites at 4 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.180  (0.0292) 0.252  (0.0318)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.072
Confidence Interval (2-Sided) 95%
0.002 to 0.143
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0355
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Mean Stain Intensity for Gingival Sites at 6 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.180  (0.0350) 0.358  (0.0375)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.178
Confidence Interval (2-Sided) 95%
0.095 to 0.260
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0415
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Mean Stain Intensity for Gingival Sites at 8 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.241  (0.0434) 0.438  (0.0485)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.197
Confidence Interval (2-Sided) 95%
0.094 to 0.300
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0520
Estimation Comments [Not Specified]
35.Secondary Outcome
Title Mean Stain Area for Gingival Sites at 4 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.186  (0.0292) 0.263  (0.0319)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.077
Confidence Interval (2-Sided) 95%
0.006 to 0.147
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0355
Estimation Comments [Not Specified]
36.Secondary Outcome
Title Mean Stain Area for Gingival Sites at 6 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.184  (0.0335) 0.352  (0.0359)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.168
Confidence Interval (2-Sided) 95%
0.089 to 0.247
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0398
Estimation Comments [Not Specified]
37.Secondary Outcome
Title Mean Stain Area for Gingival Sites at 8 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.250  (0.0430) 0.444  (0.0481)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.193
Confidence Interval (2-Sided) 95%
0.091 to 0.296
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0516
Estimation Comments [Not Specified]
38.Secondary Outcome
Title Mean Stain Score for Body Sites at 4 Weeks
Hide Description The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.132  (0.0258) 0.112  (0.0281)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.524
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.020
Confidence Interval (2-Sided) 95%
-0.082 to 0.042
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0310
Estimation Comments [Not Specified]
39.Secondary Outcome
Title Mean Stain Score for Body Sites at 6 Weeks
Hide Description The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.160  (0.0337) 0.215  (0.0361)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.172
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.055
Confidence Interval (2-Sided) 95%
-0.024 to 0.133
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0395
Estimation Comments [Not Specified]
40.Secondary Outcome
Title Mean Stain Score for Body Sites at 8 Weeks
Hide Description The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.143  (0.0371) 0.258  (0.0412)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.116
Confidence Interval (2-Sided) 95%
0.028 to 0.203
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0439
Estimation Comments [Not Specified]
41.Secondary Outcome
Title Mean Stain Intensity for Body Sites at 4 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.058  (0.0121) 0.045  (0.0132)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.348
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.014
Confidence Interval (2-Sided) 95%
-0.043 to 0.015
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0145
Estimation Comments [Not Specified]
42.Secondary Outcome
Title Mean Stain Intensity for Body Sites at 6 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.075  (0.0160) 0.100  (0.0171)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.185
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.025
Confidence Interval (2-Sided) 95%
-0.012 to 0.062
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0186
Estimation Comments [Not Specified]
43.Secondary Outcome
Title Mean Stain Intensity for Body Sites at 8 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.063  (0.0166) 0.112  (0.0184)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.049
Confidence Interval (2-Sided) 95%
0.010 to 0.088
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0196
Estimation Comments [Not Specified]
44.Secondary Outcome
Title Mean Stain Area for Body Sites at 4 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.064  (0.0133) 0.056  (0.0145)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.623
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.008
Confidence Interval (2-Sided) 95%
-0.040 to 0.024
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0160
Estimation Comments [Not Specified]
45.Secondary Outcome
Title Mean Stain Area for Body Sites at 6 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.076  (0.0158) 0.100  (0.0169)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.192
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.024
Confidence Interval (2-Sided) 95%
-0.013 to 0.061
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0186
Estimation Comments [Not Specified]
46.Secondary Outcome
Title Mean Stain Area for Body Sites at 8 Weeks
Hide Description The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.067  (0.0180) 0.124  (0.0200)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.057
Confidence Interval (2-Sided) 95%
0.014 to 0.099
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0213
Estimation Comments [Not Specified]
47.Secondary Outcome
Title Mean Stain Score for Facial Sites at 4 Weeks
Hide Description The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.063  (0.0314) 0.058  (0.0342)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.893
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.005
Confidence Interval (2-Sided) 95%
-0.081 to 0.071
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0384
Estimation Comments [Not Specified]
48.Secondary Outcome
Title Mean Stain Score for Facial Sites at 6 Weeks
Hide Description The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.118  (0.0399) 0.140  (0.0427)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.655
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.021
Confidence Interval (2-Sided) 95%
-0.073 to 0.116
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0476
Estimation Comments [Not Specified]
49.Secondary Outcome
Title Mean Stain Score for Facial Sites at 8 Weeks
Hide Description The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.097  (0.0576) 0.319  (0.0642)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.222
Confidence Interval (2-Sided) 95%
0.084 to 0.359
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0693
Estimation Comments [Not Specified]
50.Secondary Outcome
Title Mean Stain Intensity for Facial Sites at 4 Weeks
Hide Description The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.027  (0.0153) 0.025  (0.0167)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.914
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.002
Confidence Interval (2-Sided) 95%
-0.039 to 0.035
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0187
Estimation Comments [Not Specified]
51.Secondary Outcome
Title Mean Stain Intensity for Facial Sites at 6 Weeks
Hide Description The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.054  (0.0192) 0.065  (0.0206)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.646
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.011
Confidence Interval (2-Sided) 95%
-0.035 to 0.056
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0229
Estimation Comments [Not Specified]
52.Secondary Outcome
Title Mean Stain Intensity for Facial Sites at 8 Weeks
Hide Description The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.042  (0.0257) 0.144  (0.0286)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.102
Confidence Interval (2-Sided) 95%
0.040 to 0.163
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0309
Estimation Comments [Not Specified]
53.Secondary Outcome
Title Mean Stain Area for Facial Sites at 4 Weeks
Hide Description The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.032  (0.0147) 0.033  (0.0160)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.930
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.002
Confidence Interval (2-Sided) 95%
-0.034 to 0.037
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0179
Estimation Comments [Not Specified]
54.Secondary Outcome
Title Mean Stain Area for Facial Sites at 6 Weeks
Hide Description The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.059  (0.0188) 0.075  (0.0201)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.486
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.016
Confidence Interval (2-Sided) 95%
-0.029 to 0.060
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0224
Estimation Comments [Not Specified]
55.Secondary Outcome
Title Mean Stain Area for Facial Sites at 8 Weeks
Hide Description The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 46 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.047  (0.0281) 0.160  (0.0313)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.112
Confidence Interval (2-Sided) 95%
0.045 to 0.180
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0338
Estimation Comments [Not Specified]
56.Secondary Outcome
Title Mean Stain Score for Lingual Sites at 4 Weeks
Hide Description The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Crest® Regular Toothpaste 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 47 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.596  (0.0831) 0.716  (0.0910)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crest® Regular Toothpaste, 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.237
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.120