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Trial record 13 of 32 for:    FLUORIDE ION AND NITRATE ION

Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions

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ClinicalTrials.gov Identifier: NCT01641237
Recruitment Status : Completed
First Posted : July 16, 2012
Results First Posted : July 31, 2013
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Enamel Erosion
Interventions Drug: sodium fluoride
Drug: no added fluoride in a silica base
Enrollment 72
Recruitment Details Participants were recruited at the clinical site.
Pre-assignment Details A total of 72 participants were screened, and 62 were randomized into the study. 9 participants did not meet the study criteria and 1 withdrew consent. A washout non-fluoridated toothpaste was used for 2 days prior treatment. In-situ appliances were prepared for participants to fit enamel specimens.
Arm/Group Title Sodium Fluoride (NaF) Dentifrice,1426 Parts Per Million(Ppm)F NaF Dentifrice (1150ppmF) NaF Dentifrice (250ppmF) Placebo Dentifrice (0ppmF)
Hide Arm/Group Description Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 grams (g) ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided. Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided. Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided. Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Period Title: Period I
Started 16 16 15 15
Completed 16 16 15 15
Not Completed 0 0 0 0
Period Title: Period II
Started 15 [1] 16 [1] 16 [1] 15 [1]
Completed 14 16 16 15
Not Completed 1 0 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0
[1]
Due to crossover design, different set of participants entered Period 2
Period Title: Period III
Started 16 [1] 14 [1] 15 [1] 16 [1]
Completed 15 14 15 16
Not Completed 1 0 0 0
Reason Not Completed
Lost to Follow-up             1             0             0             0
[1]
Due to crossover design, different set of participants entered Period 3
Period Title: Period IV
Started 15 [1] 15 [1] 15 [1] 15 [1]
Completed 15 15 15 15
Not Completed 0 0 0 0
[1]
Due to crossover design, different set of participants entered Period 4
Arm/Group Title All Randomized Participants
Hide Arm/Group Description All randomized participants who received at least one dose of the study treatments.
Overall Number of Baseline Participants 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants
36.7  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants
Female
35
  56.5%
Male
27
  43.5%
1.Primary Outcome
Title Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship
Hide Description SMHR test was used to assess the changes in 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. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.
Time Frame Baseline to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed.
Arm/Group Title NaF Dentifrice (1426 ppmF) NaF Dentifrice (1150 ppmF) NaF Dentifrice (250 ppmF) Placebo Dentifrice (0 ppmF)
Hide Arm/Group Description:
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Overall Number of Participants Analyzed 61 61 61 60
Mean (Standard Error)
Unit of Measure: %SMHR
30.89  (1.38) 28.71  (1.38) 25.28  (1.38) 21.03  (1.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF Dentifrice (1426 ppmF), NaF Dentifrice (1150 ppmF), NaF Dentifrice (250 ppmF), Placebo Dentifrice (0 ppmF)
Comments Test for linear dose-response relationship was performed for %SMHR as a function of fluoride concentration.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NaF Dentifrice (1426 ppmF), NaF Dentifrice (1150 ppmF), NaF Dentifrice (250 ppmF), Placebo Dentifrice (0 ppmF)
Comments Test for quadratic dose-response relationship was performed for %SMHR as a function of fluoride concentration.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3748
Comments [Not Specified]
Method ANOVA
Comments Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.
2.Secondary Outcome
Title %SMHR
Hide Description SMHR test was used to assess the changes in 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. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.
Time Frame Baseline to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed.
Arm/Group Title NaF Dentifrice (1426 ppmF) NaF Dentifrice (1150 ppmF) NaF Dentifrice (250 ppmF) Placebo Dentifrice (0 ppmF)
Hide Arm/Group Description:
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Overall Number of Participants Analyzed 61 61 61 60
Mean (Standard Error)
Unit of Measure: %SMHR
30.9  (1.38) 28.7  (1.38) 25.3  (1.38) 21.0  (1.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF Dentifrice (1426 ppmF), NaF Dentifrice (1150 ppmF)
Comments Null hypothesis considered treatments in comparison to be equal.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1898
Comments No adjustment was required for multiple comparisons as the primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment and the subject as random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 2.17
Confidence Interval (2-Sided) 95%
-1.09 to 5.43
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 Dentifrice (1426 ppmF), NaF Dentifrice (250 ppmF)
Comments Null hypothesis considered no dose-response relationship between %SMHR and fluoride concentration in the dentifrice.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments No adjustment was required for multiple comparisons as the primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment and the subject as random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 5.60
Confidence Interval (2-Sided) 95%
2.35 to 8.86
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 Dentifrice (1150 ppmF), NaF Dentifrice (250 ppmF)
Comments Null hypothesis considered treatments in comparison to be equal.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0389
Comments No adjustment was required for multiple comparisons as the primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment and the subject as random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 3.43
Confidence Interval (2-Sided) 95%
0.18 to 6.68
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 Dentifrice (1426 ppmF), Placebo Dentifrice (0 ppmF)
Comments Null hypothesis considered treatments in comparison to be equal.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was required for multiple comparisons as primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment, and subject as random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 9.86
Confidence Interval (2-Sided) 95%
6.58 to 13.13
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 Dentifrice (1150 ppmF), Placebo Dentifrice (0 ppmF)
Comments Null hypothesis considered treatments in comparison to be equal.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was required for multiple comparisons as primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment, and subject as random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 7.68
Confidence Interval (2-Sided) 95%
4.41 to 10.96
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 Dentifrice (250 ppmF), Placebo Dentifrice (0 ppmF)
Comments Null hypothesis considered treatments in comparison to be equal.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0112
Comments No adjustment was required for multiple comparisons as primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment, and subject as random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 4.25
Confidence Interval (2-Sided) 95%
0.98 to 7.53
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 Percentage Relative Erosion Resistance
Hide Description Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine relative erosion resistance which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent relative erosion resistance was calculated by formula: [(E1-E2)/ (E1-B)]*100.
Time Frame Baseline to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed.
Arm/Group Title NaF Dentifrice (1426 ppmF) NaF Dentifrice (1150 ppmF) NaF Dentifrice (250 ppmF) Placebo Dentifrice (0 ppmF)
Hide Arm/Group Description:
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Overall Number of Participants Analyzed 61 61 61 60
Mean (Standard Error)
Unit of Measure: % Relative Erosion Resistance
-38.83  (2.75) -39.75  (2.75) -50.40  (2.75) -71.21  (2.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF Dentifrice (1426 ppmF), NaF Dentifrice (1150 ppmF), NaF Dentifrice (250 ppmF), Placebo Dentifrice (0 ppmF)
Comments Test for linear dose-response relationship was performed for %RER as a function of fluoride concentration.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NaF Dentifrice (1426 ppmF), NaF Dentifrice (1150 ppmF), NaF Dentifrice (250 ppmF), Placebo Dentifrice (0 ppmF)
Comments Test for quadratic dose-response relationship was performed for %RER as a function of fluoride concentration.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection NaF Dentifrice (1426 ppmF), Placebo Dentifrice (0 ppmF)
Comments Null hypothesis considered no difference between treatments, being compared.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was required for multiple comparisons as primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment, while subject was random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 32.38
Confidence Interval (2-Sided) 95%
25.18 to 39.59
Estimation Comments Difference was 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 Dentifrice (1150 ppmF), Placebo Dentifrice (0 ppmF)
Comments Null hypothesis considered no difference between treatments, being compared.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was required for multiple comparisons as primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment, while subject was random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 31.46
Confidence Interval (2-Sided) 95%
24.25 to 38.67
Estimation Comments Difference was 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 Dentifrice (250 ppmF), Placebo Dentifrice (0 ppmF)
Comments Null hypothesis considered no difference between treatments, being compared.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was required for multiple comparisons as primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment, while subject was random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 20.81
Confidence Interval (2-Sided) 95%
13.60 to 28.02
Estimation Comments Difference was 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 Dentifrice (1426 ppmF), NaF Dentifrice (1150 ppmF)
Comments Null hypothesis considered no difference between treatments, being compared.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8000
Comments No adjustment was required for multiple comparisons as primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment, while subject was random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
-6.25 to 8.10
Estimation Comments Difference was 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 Dentifrice (1426 ppmF), NaF Dentifrice (250 ppmF)
Comments Null hypothesis considered no difference between treatments, being compared.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments No adjustment was required for multiple comparisons as primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment, while subject was random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 11.57
Confidence Interval (2-Sided) 95%
4.40 to 18.74
Estimation Comments Difference was 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 Dentifrice (1150 ppmF), NaF Dentifrice (250 ppmF)
Comments Null hypothesis considered no difference between treatments, being compared.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0038
Comments No adjustment was required for multiple comparisons as primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment, while subject was random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 10.65
Confidence Interval (2-Sided) 95%
3.48 to 17.81
Estimation Comments Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.
4.Secondary Outcome
Title Enamel Fluoride Uptake (Corrected Data)
Hide Description Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of fluoride divided by area of the enamel cores. Data analysis was based on corrected data.
Time Frame Baseline to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed. Data analysis for this outcome measure was performed based on a correction factor.
Arm/Group Title NaF Dentifrice (1426 ppmF) NaF Dentifrice (1150 ppmF) NaF Dentifrice (250 ppmF) Placebo Dentifrice (0 ppmF)
Hide Arm/Group Description:
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Overall Number of Participants Analyzed 61 61 61 60
Mean (Standard Error)
Unit of Measure: micrograms*F/centimeters^2
3.13  (0.09) 3.07  (0.09) 2.09  (0.09) 1.47  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF Dentifrice (1426 ppmF), NaF Dentifrice (1150 ppmF), NaF Dentifrice (250 ppmF), Placebo Dentifrice (0 ppmF)
Comments Test for linear dose-response relationship was performed for EFU as a function of fluoride concentration.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NaF Dentifrice (1426 ppmF), NaF Dentifrice (1150 ppmF), NaF Dentifrice (250 ppmF), Placebo Dentifrice (0 ppmF)
Comments Test for quadratic dose-response relationship was performed for EFU as a function of fluoride concentration.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method ANOVA
Comments Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection NaF Dentifrice (1426 ppmF), Placebo Dentifrice (0 ppmF)
Comments Null hypothesis considered no difference between treatments, being compared.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was required for multiple comparisons as primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment, while subject was random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.66
Confidence Interval (2-Sided) 95%
1.42 to 1.90
Estimation Comments Difference was 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 Dentifrice (1150 ppmF), Placebo Dentifrice (0 ppmF)
Comments Null hypothesis considered no difference between treatments, being compared.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was required for multiple comparisons as primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment, while subject was random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.60
Confidence Interval (2-Sided) 95%
1.36 to 1.85
Estimation Comments Difference was 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 Dentifrice (250 ppmF), Placebo Dentifrice (0 ppmF)
Comments Null hypothesis considered no difference between treatments, being compared.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was required for multiple comparisons as primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment, while subject was random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.38 to 0.86
Estimation Comments Difference was 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 Dentifrice (1426 ppmF), NaF Dentifrice (1150 ppmF)
Comments Null hypothesis considered no difference between treatments, being compared.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6680
Comments No adjustment was required for multiple comparisons as primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment, while subject was random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.19 to 0.29
Estimation Comments Difference was 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 Dentifrice (1426 ppmF), NaF Dentifrice (250 ppmF)
Comments Null hypothesis considered no difference between treatments, being compared.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was required for multiple comparisons as primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment, while subject was random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.80 to 1.28
Estimation Comments Difference was 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 Dentifrice (1150 ppmF), NaF Dentifrice (250 ppmF)
Comments Null hypothesis considered no difference between treatments, being compared.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment was required for multiple comparisons as primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with fixed factors for study period and treatment, while subject was random effect.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.75 to 1.23
Estimation Comments Difference was 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 Dentifrice (1426 ppmF) NaF Dentifrice (1150 ppmF) NaF Dentifrice (250 ppmF) Placebo Dentifrice (0 ppmF)
Hide Arm/Group Description Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated.
All-Cause Mortality
NaF Dentifrice (1426 ppmF) NaF Dentifrice (1150 ppmF) NaF Dentifrice (250 ppmF) Placebo Dentifrice (0 ppmF)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NaF Dentifrice (1426 ppmF) NaF Dentifrice (1150 ppmF) NaF Dentifrice (250 ppmF) Placebo Dentifrice (0 ppmF)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/62 (0.00%)      0/61 (0.00%)      0/62 (0.00%)      0/60 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
NaF Dentifrice (1426 ppmF) NaF Dentifrice (1150 ppmF) NaF Dentifrice (250 ppmF) Placebo Dentifrice (0 ppmF)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/62 (4.84%)      6/61 (9.84%)      1/62 (1.61%)      4/60 (6.67%)    
Gastrointestinal disorders         
Mouth Ulceration  1/62 (1.61%)  1 0/61 (0.00%)  0 0/62 (0.00%)  0 2/60 (3.33%)  2
Cheilitis  0/62 (0.00%)  0 1/61 (1.64%)  1 0/62 (0.00%)  0 0/60 (0.00%)  0
Tongue Hematoma  0/62 (0.00%)  0 1/61 (1.64%)  1 0/62 (0.00%)  0 0/60 (0.00%)  0
Abdominal Pain, Upper  0/62 (0.00%)  0 0/61 (0.00%)  0 1/62 (1.61%)  1 0/60 (0.00%)  0
Sensitivity of teeth  0/62 (0.00%)  0 0/61 (0.00%)  0 0/62 (0.00%)  0 1/60 (1.67%)  1
Infections and infestations         
Nasopharyngitis  1/62 (1.61%)  1 0/61 (0.00%)  0 0/62 (0.00%)  0 0/60 (0.00%)  0
Tooth Abscess  0/62 (0.00%)  0 1/61 (1.64%)  1 0/62 (0.00%)  0 0/60 (0.00%)  0
Injury, poisoning and procedural complications         
Mouth Injury  0/62 (0.00%)  0 1/61 (1.64%)  1 0/62 (0.00%)  0 0/60 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Myalgia  0/62 (0.00%)  0 1/61 (1.64%)  1 0/62 (0.00%)  0 0/60 (0.00%)  0
Nervous system disorders         
Sinus Headache  0/62 (0.00%)  0 0/61 (0.00%)  0 0/62 (0.00%)  0 1/60 (1.67%)  1
Headache  0/62 (0.00%)  0 1/61 (1.64%)  1 0/62 (0.00%)  0 0/60 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1/62 (1.61%)  1 0/61 (0.00%)  0 0/62 (0.00%)  0 0/60 (0.00%)  0
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01641237     History of Changes
Other Study ID Numbers: RH01299
First Submitted: July 12, 2012
First Posted: July 16, 2012
Results First Submitted: May 30, 2013
Results First Posted: July 31, 2013
Last Update Posted: July 24, 2014