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Trial record 38 of 292 for:    Sodium Fluoride OR Duraphat

A Clinical Trial to Test the Effect of a Marketed Mouth Rinse on Stain Removal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02151058
Recruitment Status : Completed
First Posted : May 30, 2014
Results First Posted : June 1, 2015
Last Update Posted : June 1, 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)
Condition Tooth Stain
Interventions Drug: Colgate® Regular Cavity Protection
Drug: Experimental Mouth Rinse
Other: Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint
Enrollment 227
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Negative Control Crest 3D Investigative Mouth Rinse
Hide Arm/Group Description Colgate® Regular Cavity Protection Toothpaste (Brushing Only) Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse) Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Period Title: Overall Study
Started 45 91 91
Completed 43 90 86
Not Completed 2 1 5
Reason Not Completed
Withdrawal by Subject             1             1             3
Lost to Follow-up             1             0             2
Arm/Group Title Negative Control Crest 3D Investigative Mouth Rinse Total
Hide Arm/Group Description Colgate® Regular Cavity Protection Toothpaste (Brushing Only) Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse) Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse) Total of all reporting groups
Overall Number of Baseline Participants 45 91 91 227
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 91 participants 91 participants 227 participants
44.2  (12.57) 43.3  (12.15) 44.0  (12.40) 43.8  (12.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 91 participants 91 participants 227 participants
Female
35
  77.8%
60
  65.9%
69
  75.8%
164
  72.2%
Male
10
  22.2%
31
  34.1%
22
  24.2%
63
  27.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
USA Number Analyzed 45 participants 91 participants 91 participants 227 participants
45 91 91 227
1.Primary Outcome
Title Lobene Stain Index Composite Score at Day 15
Hide Description

Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.

The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth).

Time Frame 15 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Negative Control Crest 3D Investigative Mouth Rinse
Hide Arm/Group Description:
Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 43 90 86
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.568  (0.0821) 1.909  (0.0568) 1.575  (0.0580)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control, Crest 3D
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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.659
Confidence Interval (2-Sided) 95%
-0.8559 to -0.4622
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0999
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control, Investigative 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). Hypotheses were tested according to a hierarchical strategy.
Method ANCOVA
Comments Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.993
Confidence Interval (2-Sided) 95%
-1.1909 to -0.7946
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1005
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Crest 3D, Investigative 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). Hypotheses were tested according to a hierarchical strategy.
Method ANCOVA
Comments Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.334
Confidence Interval (2-Sided) 95%
-0.4937 to -0.1737
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0812
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Lobene Stain Index Composite Score at Day 4
Hide Description

Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.

The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth).

Time Frame 4 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Negative Control Crest 3D Investigative Mouth Rinse
Hide Arm/Group Description:
Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 43 90 88
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.527  (0.0665) 2.242  (0.0459) 2.200  (0.0464)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control, Crest 3D
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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.286
Confidence Interval (2-Sided) 95%
-0.4450 to -0.1263
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0809
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control, Investigative 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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.328
Confidence Interval (2-Sided) 95%
-0.4877 to -0.1679
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0811
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Crest 3D, Investigative 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 0.520
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.042
Confidence Interval (2-Sided) 95%
-0.1709 to 0.0866
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0653
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Lobene Stain Index Composite Score at Day 8
Hide Description

Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.

The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth).

Time Frame 8 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Negative Control Crest 3D Investigative Mouth Rinse
Hide Arm/Group Description:
Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 43 90 87
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.536  (0.0798) 2.023  (0.0551) 1.852  (0.0561)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control, Crest 3D
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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.513
Confidence Interval (2-Sided) 95%
-0.7043 to -0.3217
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0971
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control, Investigative 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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.685
Confidence Interval (2-Sided) 95%
-0.8770 to -0.4925
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0975
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Crest 3D, Investigative 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 0.030
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.172
Confidence Interval (2-Sided) 95%
-0.3268 to -0.0168
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0786
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Lobene Stain Index Area Scores at Day 4
Hide Description Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.
Time Frame 4 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Negative Control Crest 3D Investigative Mouth Rinse
Hide Arm/Group Description:
Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 43 90 88
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.621  (0.0304) 1.538  (0.0209) 1.502  (0.0212)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control, Crest 3D
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 0.026
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.083
Confidence Interval (2-Sided) 95%
-0.1556 to -0.0102
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0369
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control, Investigative 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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.118
Confidence Interval (2-Sided) 95%
-0.1917 to -0.0451
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0372
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Crest 3D, Investigative 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 0.234
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.035
Confidence Interval (2-Sided) 95%
-0.0940 to 0.0231
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0297
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Lobene Stain Index Area Scores at Day 8
Hide Description Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.
Time Frame 8 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Negative Control Crest 3D Investigative Mouth Rinse
Hide Arm/Group Description:
Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 43 90 87
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.615  (0.0468) 1.439  (0.0321) 1.265  (0.0327)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control, Crest 3D
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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.176
Confidence Interval (2-Sided) 95%
-0.2882 to -0.0644
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0568
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control, Investigative 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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.351
Confidence Interval (2-Sided) 95%
-0.4638 to -0.2378
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0573
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Crest 3D, Investigative 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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.174
Confidence Interval (2-Sided) 95%
-0.2648 to -0.0841
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0458
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Lobene Stain Index Area Scores at Day 15
Hide Description Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.
Time Frame 15 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Negative Control Crest 3D Investigative Mouth Rinse
Hide Arm/Group Description:
Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 43 90 86
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.629  (0.0520) 1.382  (0.0357) 1.131  (0.0366)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control, Crest 3D
Comments Treatment and baseline value as covariates.
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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.247
Confidence Interval (2-Sided) 95%
-0.3713 to -0.1226
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0631
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control, Investigative 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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.498
Confidence Interval (2-Sided) 95%
-0.6236 to -0.3722
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0638
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Crest 3D, Investigative 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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.251
Confidence Interval (2-Sided) 95%
-0.3516 to -0.1503
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0511
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Lobene Stain Index Intensity Scores at Day 4
Hide Description Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.
Time Frame 4 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Negative Control Crest 3D Investigative Mouth Rinse
Hide Arm/Group Description:
Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 43 90 88
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.651  (0.0306) 1.527  (0.0211) 1.483  (0.0214)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control, Crest 3D
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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.124
Confidence Interval (2-Sided) 95%
-0.1970 to -0.0504
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0372
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control, Investigative 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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.168
Confidence Interval (2-Sided) 95%
-0.2413 to -0.0941
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0373
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Crest 3D, Investigative 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 0.145
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.044
Confidence Interval (2-Sided) 95%
-0.1034 to 0.0152
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0301
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Lobene Stain Index Intensity Scores at Day 8
Hide Description Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.
Time Frame 8 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Negative Control Crest 3D Investigative Mouth Rinse
Hide Arm/Group Description:
Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 43 90 87
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.668  (0.0409) 1.438  (0.0283) 1.355  (0.0288)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control, Crest 3D
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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.230
Confidence Interval (2-Sided) 95%
-0.3282 to -0.1321
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0497
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control, Investigative 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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.313
Confidence Interval (2-Sided) 95%
-0.4113 to -0.2141
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0500
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Crest 3D, Investigative 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 0.042
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.083
Confidence Interval (2-Sided) 95%
-0.1621 to -0.0031
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0404
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Lobene Stain Index Intensity Scores at Day 15
Hide Description Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.
Time Frame 15 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Negative Control Crest 3D Investigative Mouth Rinse
Hide Arm/Group Description:
Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 43 90 86
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.671  (0.0447) 1.396  (0.0309) 1.206  (0.0316)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control, Crest 3D
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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.275
Confidence Interval (2-Sided) 95%
-0.3820 to -0.1679
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0543
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control, Investigative 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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.464
Confidence Interval (2-Sided) 95%
-0.5724 to -0.3565
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0548
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Crest 3D, Investigative 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 Treatment and baseline value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.190
Confidence Interval (2-Sided) 95%
-0.2767 to -0.1023
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0442
Estimation Comments [Not Specified]
Time Frame Day 15 ± 2 days, +30 days for serious adverse events.
Adverse Event Reporting Description Adverse events were systematically collected at each study visit through Visit 5 (Day 15 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
 
Arm/Group Title Negative Control Crest 3D Investigative Mouth Rinse
Hide Arm/Group Description Colgate® Regular Cavity Protection Toothpaste (Brushing Only) Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse) Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
All-Cause Mortality
Negative Control Crest 3D Investigative Mouth Rinse
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Negative Control Crest 3D Investigative Mouth Rinse
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/91 (0.00%)   0/91 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Negative Control Crest 3D Investigative Mouth Rinse
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/91 (0.00%)   0/91 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Principal investigator agreed not to publish the study results without prior sponsor approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Lynch, DMD, PhD/Study Director
Organization: Johnson & Johnson Consumer and Personal Products Worldwide
Phone: 908-433-6423 USA EST
EMail: mlynch23@its.jnj.com
Layout table for additonal information
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT02151058     History of Changes
Other Study ID Numbers: CO-131219112750-CTOC
First Submitted: May 27, 2014
First Posted: May 30, 2014
Results First Submitted: May 7, 2015
Results First Posted: June 1, 2015
Last Update Posted: June 1, 2015