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Evaluation of Plaque Fluid Fluoride Retention From 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: NCT00708305
Recruitment Status : Completed
First Posted : July 2, 2008
Results First Posted : June 10, 2013
Last Update Posted : January 1, 2015
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
Condition Dental Caries
Interventions Drug: Sodium Fluoride (NaF)
Drug: Placebo
Enrollment 65
Recruitment Details Participants were recruited at the clinical site.
Pre-assignment Details There was a four-day wash out prior to each treatment period during which participants used the study fluoride-free toothpaste. Two to three days prior to the start of each treatment visit, participants attended the study site for a dental prophylaxis then discontinued all oral hygiene prior to study treatment visit.
Arm/Group Title Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F) NaF Toothpaste (1400ppmF) Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF) Placebo Toothpaste (0ppmF)
Hide Arm/Group Description Participants brushed their natural teeth for one timed minute with 1.6 grams (g) of with NaF and 0.4% carbopol toothpaste (1450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. Participants brushed their natural teeth for one timed minute with 1.6 g NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. Participants brushed their natural teeth for one timed minute with 1.6 g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Period Title: Period 1
Started 16 16 17 16
Completed 15 16 16 14
Not Completed 1 0 1 2
Reason Not Completed
Protocol Violation             1             0             1             0
Other Reason             0             0             0             2
Period Title: Period 2
Started 15 [1] 15 [1] 16 [1] 15 [1]
Completed 14 13 16 14
Not Completed 1 2 0 1
Reason Not Completed
Lost to Follow-up             0             1             0             0
Protocol Violation             0             1             0             0
Other Reason             1             0             0             1
[1]
Due to crossover design, different set of participants received this treatment compared to Period 1
Period Title: Period 3
Started 15 [1] 14 [1] 14 [1] 14 [1]
Completed 14 12 14 14
Not Completed 1 2 0 0
Reason Not Completed
Protocol Violation             0             2             0             0
Other Reason             1             0             0             0
[1]
Due to crossover design, different set of participants received this treatment compared to Period 2
Period Title: Period 4
Started 12 [1] 14 [1] 14 [1] 14 [1]
Completed 12 14 14 14
Not Completed 0 0 0 0
[1]
Due to crossover design, different set of participants received this treatment compared to Period 3
Arm/Group Title Overall Study
Hide Arm/Group Description All randomized participants
Overall Number of Baseline Participants 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants
26.4  (6.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
Female
31
  47.7%
Male
34
  52.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 65 participants
65
1.Primary Outcome
Title Natural Log Transformed Area Under the Fluoride Concentration in Plaque Fluid by Time Curve (AUC) Between 0-4 Hours
Hide Description To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4hours using trapezoidal rule and natural log transformation was applied due to failure of assumption of normal distribution of data.
Time Frame Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol (PP) population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed.
Arm/Group Title NaF Toothpaste(1450 Ppm F) NaF Toothpaste (1400 Ppm F)
Hide Arm/Group Description:
Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Overall Number of Participants Analyzed 58 57
Least Squares Mean (Standard Error)
Unit of Measure: ln(μg*F*minutes/cm^2)
0.54  (0.086) 0.54  (0.087)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste(1450 Ppm F), NaF Toothpaste (1400 Ppm F)
Comments Null hypothesis is no difference between treatments in comparison. Tests were 2-sided at 5% significance levels.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9762
Comments No adjustment was made for multiple comparisons as the primary comparison was predefined.
Method ANCOVA
Comments The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.00
Confidence Interval 95%
-0.21 to 0.20
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 Natural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours
Hide Description To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4 hours using trapezoidal rule and natural log transformation was applied.due to failure of assumption of normal distribution of data.
Time Frame Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol (PP) population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed.
Arm/Group Title NaF Toothpaste(1450ppmF) NaF Toothpaste (1400ppmF) NaMFP/NaF Toothpaste (1450ppmF) Placebo Toothpaste (0ppmF)
Hide Arm/Group Description:
Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Overall Number of Participants Analyzed 58 57 58 56
Log Mean (Standard Error)
Unit of Measure: ln(μg*F*minutes/cm^2)
0.54  (0.086) 0.54  (0.087) 0.05  (0.086) -0.90  (0.087)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste(1450ppmF), NaMFP/NaF Toothpaste (1450ppmF)
Comments Null hypothesis is no difference between treatments being compared. Tests were 2 sided at 5% significance levels.
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 comparisons were predefined.
Method ANCOVA
Comments The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.
Method of Estimation Estimation Parameter Adjusted Mean DIfference
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.28 to 0.70
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(1450ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.
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 because the comparisons were predefined.
Method ANCOVA
Comments The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.44
Confidence Interval 95%
1.23 to 1.65
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 (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.
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 because the comparisons were predefined.
Method ANCOVA
Comments The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.49
Confidence Interval 95%
0.28 to 0.70
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 (1400ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.
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 because the comparison was predefined.
Method ANCOVA
Comments The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.44
Confidence Interval (2-Sided) 95%
1.23 to 1.65
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 NaMFP/NaF Toothpaste (1450ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.
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 comparisons were predefined.
Method ANCOVA
Comments The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.74 to 1.16
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 Change From Baseline in Fluoride Concentration at 15 Minutes After Brushing With Study Treatments
Hide Description Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Time Frame Plaque samples were collected at baseline, 15 minutes post single application of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed.
Arm/Group Title NaF Toothpaste(1450ppmF) NaF Toothpaste (1400ppmF) NaMFP/NaF Toothpaste (1450ppmF) Placebo Toothpaste (0ppmF)
Hide Arm/Group Description:
Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Overall Number of Participants Analyzed 58 59 60 58
Median (Full Range)
Unit of Measure: μg*F/g
2.00
(0.1 to 21.7)
1.56
(0.1 to 16.0)
0.76
(0.1 to 7.2)
0.03
(-0.3 to 0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste(1450ppmF), NaF Toothpaste (1400ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0151
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.12 to 1.72
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste(1450ppmF), NaMFP/NaF Toothpaste (1450ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical 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 for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
0.69 to 2.36
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(1450ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis is no difference between treatments. Tests were 2-sided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 3.01
Confidence Interval (2-Sided) 95%
2.06 to 4.05
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical 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 for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.41 to 1.27
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 Toothpaste (1400ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical 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 for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 2.10
Confidence Interval (2-Sided) 95%
1.50 to 2.74
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 NaMFP/NaF Toothpaste (1450ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical 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 for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.73 to 1.35
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
4.Secondary Outcome
Title Change From Baseline in Fluoride Concentration at 30 Minutes Post Brushing With Study Treatments
Hide Description Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Time Frame Plaque samples were collected at baseline, 30 minutes post single application of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed.
Arm/Group Title NaF Toothpaste(1450ppmF) NaF Toothpaste (1400ppmF) NaMFP/NaF Toothpaste (1450ppmF) Placebo Toothpaste (0ppmF)
Hide Arm/Group Description:
Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Overall Number of Participants Analyzed 58 58 60 58
Median (Full Range)
Unit of Measure: μg*F/g
0.71
(0.0 to 7.7)
0.72
(0.0 to 14.9)
0.28
(0.0 to 4.7)
0.02
(-0.3 to 0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste(1450ppmF), NaF Toothpaste (1400ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5545
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.22 to 0.47
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(1450ppmF), NaMFP/NaF Toothpaste (1450ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
0.15 to 0.71
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste(1450ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical 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 for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.58 to 1.56
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 (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical 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 for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signal Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.15 to 0.68
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1400ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical 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 for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.58 to 1.35
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 NaMFP/NaF Toothpaste (1450ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical 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 for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
0.26 to 0.56
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
5.Secondary Outcome
Title Change From Baseline in Fluoride Concentration at 1 Hour Post Brushing With Study Treatments
Hide Description Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Time Frame Plaque samples were collected at baseline, 1 hour post single application of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed.
Arm/Group Title NaF Toothpaste(1450ppmF) NaF Toothpaste (1400ppmF) NaMFP/NaF Toothpaste (1450ppmF) Placebo Toothpaste (0ppmF)
Hide Arm/Group Description:
Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Overall Number of Participants Analyzed 58 58 58 58
Median (Full Range)
Unit of Measure: μg*F/g
0.20
(0.0 to 3.1)
0.22
(0.0 to 6.7)
0.12
(0.0 to 1.6)
0.01
(0.00 to 0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste(1450ppmF), NaF Toothpaste (1400ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6865
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.13 to 0.08
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste(1450ppmF), NaMFP/NaF Toothpaste (1450ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1756
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.02 to 0.12
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(1450ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical 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 for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
0.16 to 0.38
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 (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
0.04 to 0.22
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 Toothpaste (1400ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical 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 for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
0.22 to 0.51
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 NaMFP/NaF Toothpaste (1450ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical 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 for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
0.12 to 0.25
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
6.Secondary Outcome
Title Change From Baseline in Fluoride Concentration at 2 Hours Post Brushing With Study Treatments
Hide Description Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Time Frame Plaque samples were collected at baseline, 2 hour post single application of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed.
Arm/Group Title NaF Toothpaste(1450ppmF) NaF Toothpaste (1400ppmF) NaMFP/NaF Toothpaste (1450ppmF) Placebo Toothpaste (0ppmF)
Hide Arm/Group Description:
Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Overall Number of Participants Analyzed 58 59 58 57
Median (Full Range)
Unit of Measure: μg*F/g
0.09
(-0.1 to 0.7)
0.09
(-0.1 to 1.0)
0.07
(-0.3 to 0.5)
0.00
(-0.1 to 0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste(1450ppmF), NaF Toothpaste (1400ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0783
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.08 to 0.00
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste(1450ppmF), NaMFP/NaF Toothpaste (1450ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0531
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
0.00 to 0.07
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(1450ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical 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 for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
0.07 to 0.14
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 (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
0.03 to 0.15
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 Toothpaste (1400ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical 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 for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
0.08 to 0.20
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 NaMFP/NaF Toothpaste (1450ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical 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 for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
0.04 to 0.10
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
7.Secondary Outcome
Title Change From Baseline in Fluoride Concentration at 4 Hours Post Brushing With Study Treatments
Hide Description Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Time Frame Plaque samples were collected at baseline, 4 hours post single application of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the "n" per treatment group. Missing data was not imputed.
Arm/Group Title NaF Toothpaste(1450ppmF) NaF Toothpaste (1400ppmF) NaMFP/NaF Toothpaste (1450ppmF) Placebo Toothpaste (0ppmF)
Hide Arm/Group Description:
Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds
Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Overall Number of Participants Analyzed 57 57 60 57
Median (Full Range)
Unit of Measure: μg*F/g
0.04
(-0.1 to 0.7)
0.04
(-0.1 to 1.2)
0.02
(-0.3 to 0.2)
-0.01
(-0.1 to 0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste(1450ppmF), NaF Toothpaste (1400ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4309
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.03 to 0.01
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste(1450ppmF), NaMFP/NaF Toothpaste (1450ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0726
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
0.00 to 0.04
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(1450ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical 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 for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
0.03 to 0.06
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 (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0107
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
0.01 to 0.06
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 Toothpaste (1400ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical 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 [Not Specified]
Method Wilcoxon Signed Rank Test
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
0.03 to 0.07
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 NaMFP/NaF Toothpaste (1450ppmF), Placebo Toothpaste (0ppmF)
Comments Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
0.01 to 0.04
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Time Frame All adverse events 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 Toothpaste(1450ppmF) NaF Toothpaste (1400ppmF) NaMFP/NaF Toothpaste (1450ppmF) Placebo Toothpaste (0ppmF)
Hide Arm/Group Description Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
All-Cause Mortality
NaF Toothpaste(1450ppmF) NaF Toothpaste (1400ppmF) NaMFP/NaF Toothpaste (1450ppmF) Placebo Toothpaste (0ppmF)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
NaF Toothpaste(1450ppmF) NaF Toothpaste (1400ppmF) NaMFP/NaF Toothpaste (1450ppmF) Placebo Toothpaste (0ppmF)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/59 (0.00%)   0/61 (0.00%)   0/59 (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 Toothpaste(1450ppmF) NaF Toothpaste (1400ppmF) NaMFP/NaF Toothpaste (1450ppmF) Placebo Toothpaste (0ppmF)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/59 (0.00%)   0/61 (0.00%)   0/59 (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.
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: NCT00708305     History of Changes
Other Study ID Numbers: T3508570
First Submitted: July 1, 2008
First Posted: July 2, 2008
Results First Submitted: September 14, 2010
Results First Posted: June 10, 2013
Last Update Posted: January 1, 2015