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A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model

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: NCT01607411
Recruitment Status : Completed
First Posted : May 30, 2012
Results First Posted : August 26, 2013
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Dental Caries
Interventions Drug: Fluoride
Drug: Placebo
Enrollment 55
Recruitment Details Participants were recruited at the clinical site.
Pre-assignment Details Of the 70 participants screened, 15 were not randomized into the study (12 did not meet study criteria and 3 withdrew the consent). A washout fluoride (F) toothpaste was used for a week prior treatment. In-situ appliances were prepared for participants to fit enamel specimens.
Arm/Group Title Sodium Fluoride(NaF) Toothpaste (1426parts Per Million(Ppm) F) NaF Toothpaste (1000 Ppm F) NaF Toothpaste (500 Ppm F) Placebo Toothpaste (0 Ppm F)
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 1.0 grams (g) ± 0.1g of NaF toothpaste(1426 ppm F) 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 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) 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 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) 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 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
Period Title: Period I
Started 14 13 14 14
Completed 14 13 14 14
Not Completed 0 0 0 0
Period Title: Period II
Started 14 [1] 14 [1] 13 [1] 14 [1]
Completed 14 14 13 14
Not Completed 0 0 0 0
[1]
Due to crossover design, different set of participants entered Period 2
Period Title: Period III
Started 14 [1] 14 [1] 14 [1] 13 [1]
Completed 14 14 14 13
Not Completed 0 0 0 0
[1]
Due to crossover design, different set of participants entered Period 3
Period Title: Period IV
Started 13 [1] 14 [1] 14 [1] 14 [1]
Completed 13 14 14 14
Not Completed 0 0 0 0
[1]
Due to crossover design, different set of participants entered Period 4
Arm/Group Title Overall
Hide Arm/Group Description All randomized participants who received atleast one dose of the study treatments
Overall Number of Baseline Participants 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants
12.4  (1.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Female
31
  56.4%
Male
24
  43.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants
Black or African American 9
White 41
More than one race 5
1.Primary Outcome
Title Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice
Hide Description Surface microhardness recovery (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 demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.
Time Frame Baseline to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (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 enamel specimen values were imputed, by averaging over the available enamel specimens.
Arm/Group Title NaF Toothpaste (1426 Ppm F) NaF Toothpaste (1000 Ppm F) NaF Toothpaste (500 Ppm F) Placebo Toothpaste (0 Ppm F)
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 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) 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 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) 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 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) 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 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
Overall Number of Participants Analyzed 55 55 55 55
Mean (Standard Error)
Unit of Measure: %SMHR
30.72  (0.87) 29.49  (0.87) 28.29  (0.87) 25.13  (0.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1426 Ppm F), Placebo Toothpaste (0 Ppm F)
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 required for multiple comparisons as the primary comparison was pre-specified.
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 5.59
Confidence Interval (2-Sided) 95%
3.60 to 7.58
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1000 Ppm F), Placebo Toothpaste (0 Ppm F)
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 required for multiple comparisons as the primary comparison was pre-specified
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 4.36
Confidence Interval (2-Sided) 95%
2.37 to 6.35
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (500 Ppm F), Placebo Toothpaste (0 Ppm F)
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 0.0021
Comments No adjustment was required for multiple comparisons as the primary comparison was pre-specified
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 3.16
Confidence Interval (2-Sided) 95%
1.17 to 5.15
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 %SMHR of Enamel Specimens Exposed to Test Treatments
Hide Description Surface microhardness recovery (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 demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.
Time Frame Baseline to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (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 enamel specimen values were imputed, by averaging over the available enamel specimens.
Arm/Group Title NaF Toothpaste (1426 Ppm F) NaF Toothpaste (1000 Ppm F) NaF Toothpaste (500 Ppm F)
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 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) 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 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) 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 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
Overall Number of Participants Analyzed 55 55 55
Mean (Standard Error)
Unit of Measure: %SMHR
30.72  (0.87) 29.49  (0.87) 28.29  (0.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1426 Ppm F), NaF Toothpaste (1000 Ppm F)
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 0.2225
Comments No adjustment was required for multiple comparisons as the primary comparison was pre-specified
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
-0.76 to 3.22
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1426 Ppm F), NaF Toothpaste (500 Ppm F)
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 0.0168
Comments No adjustment was required for multiple comparisons as the primary comparison was pre-specified
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 2.44
Confidence Interval (2-Sided) 95%
0.44 to 4.43
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1000 Ppm F), NaF Toothpaste (500 Ppm F)
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 0.2352
Comments No adjustment was required for multiple comparisons as the primary comparison was pre-specified
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.20
Confidence Interval (2-Sided) 95%
-0.79 to 3.19
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 Percent Net Acid Resistance (%NAR) of Enamel Specimens
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 NAR which compared the indentations values of sound enamel specimens at baseline (B), first demineralization challenge (D1) and second demineralization challenge (D2). Percent NAR was calculated by formula: [(D1-D2)/ (D1-B)]*100.
Time Frame Baseline to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (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 enamel specimen values were imputed, by averaging over the available enamel specimens.
Arm/Group Title NaF Toothpaste (1426 Ppm F) NaF Toothpaste (1000 Ppm F) NaF Toothpaste (500 Ppm F) Placebo Toothpaste (0 Ppm F)
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 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) 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 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) 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 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) 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 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
Overall Number of Participants Analyzed 55 55 55 55
Mean (Standard Error)
Unit of Measure: %NAR
-19.72  (1.90) -19.52  (1.90) -25.82  (1.90) -54.38  (1.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1426 Ppm F), Placebo Toothpaste (0 Ppm F)
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 required for multiple comparisons as the primary comparison was pre-specified
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 34.65
Confidence Interval (2-Sided) 95%
30.07 to 39.24
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1000 Ppm F), Placebo Toothpaste (0 Ppm F)
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 required for multiple comparisons as the primary comparison was pre-specified
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random effect
Method of Estimation Estimation Parameter Adjusted Mean difference
Estimated Value 34.86
Confidence Interval (2-Sided) 95%
30.28 to 39.44
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (500 Ppm F), Placebo Toothpaste (0 Ppm F)
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 required for multiple comparisons as the primary comparison was pre-specified
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 28.55
Confidence Interval (2-Sided) 95%
23.97 to 33.13
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1426 Ppm F), NaF Toothpaste (1000 Ppm F)
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 0.9292
Comments No adjustment was required for multiple comparisons as the primary comparison was pre-specified
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-4.79 to 4.38
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1426 Ppm F), NaF Toothpaste (500 Ppm F)
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 0.0094
Comments No adjustment was required for multiple comparisons as the primary comparison was pre-specified
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 6.10
Confidence Interval (2-Sided) 95%
1.52 to 10.69
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1000 Ppm F), NaF Toothpaste (500 Ppm F)
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 0.0073
Comments No adjustment was required for multiple comparisons as the primary comparison was pre-specified
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 6.31
Confidence Interval (2-Sided) 95%
1.72 to 10.89
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 Enamel Fluoride Uptake
Hide Description Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of F divided by volume of the enamel cores and expressed as micrograms (μg)* F/centimeters(cm)^2. Difference between treatments was calculated with respect to F uptake by enamel.
Time Frame Baseline to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (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 enamel specimen values were imputed, by averaging over the available enamel specimens
Arm/Group Title NaF Toothpaste (1426 Ppm F) NaF Toothpaste (1000 Ppm F) NaF Toothpaste (500 Ppm F) Placebo Toothpaste (0 Ppm F)
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 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) 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 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) 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 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) 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 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
Overall Number of Participants Analyzed 55 55 55 55
Mean (Standard Error)
Unit of Measure: μg*F/cm^2
1.76  (0.08) 1.77  (0.08) 1.47  (0.08) 0.98  (0.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1426 Ppm F), Placebo Toothpaste (0 Ppm F)
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 required for multiple comparisons as the primary comparison was pre-specified
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random factor
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.58 to 0.98
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1000 Ppm F), Placebo Toothpaste (0 Ppm F)
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 required for multiple comparisons as the primary comparison was pre-specified
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.58 to 0.99
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (500 Ppm F), Placebo Toothpaste (0 Ppm F)
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 required for multiple comparisons as the primary comparison was pre-specified
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.29 to 0.69
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1426 Ppm F), NaF Toothpaste (1000 Ppm F)
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 0.9631
Comments No adjustment was required for multiple comparisons as the primary comparison was pre-specified
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.005
Confidence Interval (2-Sided) 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
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1426 Ppm F), NaF Toothpaste (500 Ppm F)
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 0.0047
Comments No adjustment was required for multiple comparisons as the primary comparison was pre-specified
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.29
Confidence Interval (2-Sided) 95%
0.09 to 0.49
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection NaF Toothpaste (1000 Ppm F), NaF Toothpaste (500 Ppm F)
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 0.0040
Comments No adjustment was required for multiple comparisons as the primary comparison was pre-specified
Method ANOVA
Comments The fixed factors for ANOVA were study period and treatment and the subject was random effect
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
0.10 to 0.50
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
Time Frame Baseline through 5 days post administration of last treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NaF Toothpaste (1426 Ppm F) NaF Toothpaste (1000 Ppm F) NaF Toothpaste (500 Ppm F) Placebo Toothpaste (0 Ppm F)
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 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) 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 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) 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 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) 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 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
All-Cause Mortality
NaF Toothpaste (1426 Ppm F) NaF Toothpaste (1000 Ppm F) NaF Toothpaste (500 Ppm F) Placebo Toothpaste (0 Ppm F)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
NaF Toothpaste (1426 Ppm F) NaF Toothpaste (1000 Ppm F) NaF Toothpaste (500 Ppm F) Placebo Toothpaste (0 Ppm F)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/55 (0.00%)      0/55 (0.00%)      0/55 (0.00%)      0/55 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
NaF Toothpaste (1426 Ppm F) NaF Toothpaste (1000 Ppm F) NaF Toothpaste (500 Ppm F) Placebo Toothpaste (0 Ppm F)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/55 (7.27%)      6/55 (10.91%)      7/55 (12.73%)      6/55 (10.91%)    
Ear and labyrinth disorders         
Sinusitis  0/55 (0.00%)  0 1/55 (1.82%)  1 1/55 (1.82%)  1 0/55 (0.00%)  0
Ear infection  1/55 (1.82%)  1 0/55 (0.00%)  0 0/55 (0.00%)  0 0/55 (0.00%)  0
Gastrointestinal disorders         
Oral herpes  0/55 (0.00%)  0 0/55 (0.00%)  0 1/55 (1.82%)  1 1/55 (1.82%)  1
Musculoskeletal and connective tissue disorders         
Myalgia  0/55 (0.00%)  0 1/55 (1.82%)  1 0/55 (0.00%)  0 0/55 (0.00%)  0
Gingival erythema  0/55 (0.00%)  0 0/55 (0.00%)  0 0/55 (0.00%)  0 1/55 (1.82%)  1
Nervous system disorders         
Headache  1/55 (1.82%)  1 2/55 (3.64%)  2 2/55 (3.64%)  2 0/55 (0.00%)  0
Renal and urinary disorders         
Blood urine present  0/55 (0.00%)  0 0/55 (0.00%)  0 0/55 (0.00%)  0 1/55 (1.82%)  1
Respiratory, thoracic and mediastinal disorders         
Nasopharyngitis  0/55 (0.00%)  0 0/55 (0.00%)  0 2/55 (3.64%)  2 1/55 (1.82%)  1
Pharyngitis streptococcal  0/55 (0.00%)  0 1/55 (1.82%)  1 1/55 (1.82%)  1 0/55 (0.00%)  0
Skin and subcutaneous tissue disorders         
Lip injury  2/55 (3.64%)  2 0/55 (0.00%)  0 0/55 (0.00%)  0 1/55 (1.82%)  1
Rash  0/55 (0.00%)  0 1/55 (1.82%)  1 0/55 (0.00%)  0 0/55 (0.00%)  0
Chapped lips  0/55 (0.00%)  0 0/55 (0.00%)  0 0/55 (0.00%)  0 1/55 (1.82%)  1
1
Term from vocabulary, MedDRA
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
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01607411    
Other Study ID Numbers: RH01390
First Submitted: February 16, 2012
First Posted: May 30, 2012
Results First Submitted: May 30, 2013
Results First Posted: August 26, 2013
Last Update Posted: August 11, 2014