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In Situ Caries of Fluoride Toothpastes

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: NCT00708123
Recruitment Status : Completed
First Posted : July 2, 2008
Results First Posted : November 19, 2012
Last Update Posted : April 22, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Healthy Subjects
Partial Denture Wearers
Caries
Interventions Drug: Sodium fluoride toothpaste
Drug: Placebo toothpaste
Enrollment 60
Recruitment Details Participants were recruited at the clinical site.
Pre-assignment Details Two days, prior to each treatment visit ,participants used a fluoride- free dentifrice twice daily to avoid any carry over effect.
Arm/Group Title Sodium Fluoride (NaF) Toothpaste[1350 Parts Per Million(Ppm)F] NaF/Carbopol Toothpaste (1400 Ppm F) NaMFP/NaF Toothpaste (1450 Ppm F) NaF Toothpaste (250 Ppm F) Placebo Toothpaste (0 Ppm F)
Hide Arm/Group Description Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
Period Title: Period 1
Started 12 12 12 12 12
Completed 12 11 11 11 12
Not Completed 0 1 1 1 0
Reason Not Completed
Protocol Violation             0             1             0             1             0
Adverse Event             0             0             1             0             0
Period Title: Period 2
Started 11 [1] 12 [2] 12 [2] 11 [1] 11 [1]
Completed 10 12 12 10 11
Not Completed 1 0 0 1 0
Reason Not Completed
Protocol Violation             0             0             0             1             0
Other Reason             1             0             0             0             0
[1]
Due to crossover design, different set of participants received this treatment compared to Period 1
[2]
Due to crossover design,different set of participants received this treatment compared to Period 1
Period Title: Period 3
Started 12 [1] 10 [1] 11 [1] 12 [1] 10 [1]
Completed 12 10 10 11 10
Not Completed 0 0 1 1 0
Reason Not Completed
Lost to Follow-up             0             0             1             1             0
[1]
Due to crossover design, different set of participants received this treatment compared to Period 2
Period Title: Period 4
Started 10 [1] 12 [1] 10 [1] 10 [1] 11 [1]
Completed 10 11 10 10 11
Not Completed 0 1 0 0 0
Reason Not Completed
Protocol Violation             0             1             0             0             0
[1]
Due to crossover design, different set of participants received this treatment compared to Period 3
Period Title: Period 5
Started 10 [1] 10 [1] 11 [1] 11 [1] 10 [1]
Completed 10 10 11 11 10
Not Completed 0 0 0 0 0
[1]
Due to crossover design, different set of participants received this treatment compared to Period 4
Arm/Group Title All Study Participants
Hide Arm/Group Description All randomized participants were included for baseline evaluation.
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
67.31  (9.166)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
33
  55.0%
Male
27
  45.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants
60
1.Primary Outcome
Title Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)
Hide Description %SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.
Time Frame Baseline to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to subject drop outs, there are differences in the "n" per treatment group.
Arm/Group Title NaF/Carbopol Toothpaste (1400 Ppm F) NaF Toothpaste (1350 Ppm F) NaMFP/NaF Toothpaste (1450 Ppm F)
Hide Arm/Group Description:
Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial dentures from their mouth.
Overall Number of Participants Analyzed 54 53 54
Least Squares Mean (Standard Error)
Unit of Measure: %SMHR
33.54  (1.72) 35.23  (1.74) 29.57  (1.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF/Carbopol Toothpaste (1400 Ppm F), NaMFP/NaF Toothpaste (1450 Ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0265
Comments No adjustment was made for multiple comparisons as primary comparisons were pre-defined.
Method ANOVA
Comments The analysis included factors treatment, period and subject as a random effect.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 3.97
Confidence Interval (2-Sided) 95%
0.47 to 7.48
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1350 Ppm F), NaMFP/NaF Toothpaste (1450 Ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments No adjustment was made for multiple comparisons as primary comparisons were pre-defined.
Method ANOVA
Comments The analysis included factors as treatment, period and subject as a random effect.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 5.66
Confidence Interval (2-Sided) 95%
2.15 to 9.18
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
2.Secondary Outcome
Title Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF)
Hide Description %SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.
Time Frame Baseline to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs, there were differences in the "n" per treatment group.
Arm/Group Title NaF/Carbopol Toothpaste (1400 Ppm F) NaF Toothpaste (1350ppm F) NaF Toothpaste (250 Ppm F) NaMFP/NaF Toothpaste (1450 Ppm F) Placebo Toothpaste (0 Ppm F)
Hide Arm/Group Description:
Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
Overall Number of Participants Analyzed 54 53 54 54 54
Least Squares Mean (Standard Error)
Unit of Measure: %SMHR
33.54  (1.72) 35.23  (1.74) 24.98  (1.72) 29.57  (1.72) 22.05  (1.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF/Carbopol Toothpaste (1400 Ppm F), NaF Toothpaste (1350ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3413
Comments No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject as random effect
Method of Estimation Estimation Parameter Adjusted Mean DIfference
Estimated Value -1.69
Confidence Interval (2-Sided) 95%
-5.19 to 1.80
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1350ppm F), NaF Toothpaste (250 Ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustments made for multiple comparisons as the primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject as random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 10.26
Confidence Interval (2-Sided) 95%
6.76 to 13.76
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1350ppm F), Placebo Toothpaste (0 Ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject as random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 13.19
Confidence Interval (2-Sided) 95%
9.69 to 16.68
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection NaF/Carbopol Toothpaste (1400 Ppm F), NaF Toothpaste (250 Ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject as random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 8.57
Confidence Interval (2-Sided) 95%
5.09 to 12.05
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection NaF/Carbopol Toothpaste (1400 Ppm F), Placebo Toothpaste (0 Ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject (random effect).
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 11.50
Confidence Interval (2-Sided) 95%
8.01 to 14.98
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (250 Ppm F), NaMFP/NaF Toothpaste (1450 Ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0104
Comments No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject as random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -4.59
Confidence Interval (2-Sided) 95%
-8.10 to -1.09
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection NaMFP/NaF Toothpaste (1450 Ppm F), Placebo Toothpaste (0 Ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject as random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 7.52
Confidence Interval (2-Sided) 95%
4.04 to 11.01
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (250 Ppm F), Placebo Toothpaste (0 Ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0986
Comments No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject as random effect.
Method of Estimation Estimation Parameter Adjusted Mean DIfference
Estimated Value 2.93
Confidence Interval (2-Sided) 95%
-0.55 to 6.41
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
3.Secondary Outcome
Title Adjusted Mean Change From Baseline in Enamel Fluoride Uptake
Hide Description Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug F/cm2. The difference between treatments was calculated with respect to fluoride uptake by enamel.
Time Frame Baseline to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomized participants who had a least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs, there were differences in the "n" per treatment group.
Arm/Group Title NaF/ Carbopol Toothpaste (1400 Ppm F) NaF Toothpaste (1350ppm F) NaF Toothpaste (250 Ppm F) NaMFP/NaF Toothpaste (1450 Ppm F) Placebo Toothpaste (0 Ppm F)
Hide Arm/Group Description:
Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
Overall Number of Participants Analyzed 54 53 54 54 54
Least Squares Mean (Standard Error)
Unit of Measure: µg*F/cm^2
1283.13  (71.53) 1333.09  (72.08) 680.20  (71.48) 1086.39  (71.42) 435.58  (71.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF/ Carbopol Toothpaste (1400 Ppm F), NaMFP/NaF Toothpaste (1450 Ppm F)
Comments Null hypothesis was no difference between treatments. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0148
Comments No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject as random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 196.74
Confidence Interval (2-Sided) 95%
38.89 to 354.60
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1350ppm F), NaMFP/NaF Toothpaste (1450 Ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject as random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 246.70
Confidence Interval (2-Sided) 95%
88.30 to 405.10
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection NaF/ Carbopol Toothpaste (1400 Ppm F), NaF Toothpaste (1350ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5328
Comments No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject as random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -49.96
Confidence Interval (2-Sided) 95%
-207.62 to 107.71
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (250 Ppm F), NaMFP/NaF Toothpaste (1450 Ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject as random effect
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -406.19
Confidence Interval (2-Sided) 95%
-564.00 to -248.37
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection NaF/ Carbopol Toothpaste (1400 Ppm F), NaF Toothpaste (250 Ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject as random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 602.93
Confidence Interval (2-Sided) 95%
445.97 to 759.90
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1350ppm F), NaF Toothpaste (250 Ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject as random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 652.89
Confidence Interval (2-Sided) 95%
495.05 to 810.72
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection NaF/ Carbopol Toothpaste (1400 Ppm F), Placebo Toothpaste (0 Ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject as random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 847.55
Confidence Interval (2-Sided) 95%
690.54 to 1004.55
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1350ppm F), Placebo Toothpaste (0 Ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.
Method ANOVA
Comments ANOVA with factors treatment, period and subject as random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 897.50
Confidence Interval (2-Sided) 95%
739.92 to 1055.08
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection NaMFP/NaF Toothpaste (1450 Ppm F), Placebo Toothpaste (0 Ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject as random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 650.80
Confidence Interval (2-Sided) 95%
493.61 to 808.00
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (250 Ppm F), Placebo Toothpaste (0 Ppm F)
Comments Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject as random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 244.62
Confidence Interval (2-Sided) 95%
87.62 to 401.61
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Time Frame All AEs encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NaF/ Carbopol Toothpaste (1400 Ppm F) NaF Toothpaste (1350ppm F) NaMFP/NaF Toothpaste (1450 Ppm F) NaF Toothpaste (250 Ppm F) Placebo Toothpaste (0 Ppm F)
Hide Arm/Group Description Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
All-Cause Mortality
NaF/ Carbopol Toothpaste (1400 Ppm F) NaF Toothpaste (1350ppm F) NaMFP/NaF Toothpaste (1450 Ppm F) NaF Toothpaste (250 Ppm F) Placebo Toothpaste (0 Ppm F)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NaF/ Carbopol Toothpaste (1400 Ppm F) NaF Toothpaste (1350ppm F) NaMFP/NaF Toothpaste (1450 Ppm F) NaF Toothpaste (250 Ppm F) Placebo Toothpaste (0 Ppm F)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/56 (0.00%)      0/54 (0.00%)      0/55 (0.00%)      0/56 (0.00%)      0/54 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NaF/ Carbopol Toothpaste (1400 Ppm F) NaF Toothpaste (1350ppm F) NaMFP/NaF Toothpaste (1450 Ppm F) NaF Toothpaste (250 Ppm F) Placebo Toothpaste (0 Ppm F)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/56 (7.14%)      4/54 (7.41%)      1/55 (1.82%)      1/56 (1.79%)      2/54 (3.70%)    
Infections and infestations           
Nasopharyngitis  4/56 (7.14%)  4 4/54 (7.41%)  4 1/55 (1.82%)  1 1/56 (1.79%)  1 2/54 (3.70%)  2
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00708123     History of Changes
Other Study ID Numbers: T3157503
First Submitted: July 1, 2008
First Posted: July 2, 2008
Results First Submitted: September 14, 2010
Results First Posted: November 19, 2012
Last Update Posted: April 22, 2013