Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion

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: NCT01657903
Recruitment Status : Completed
First Posted : August 6, 2012
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Dental Erosion
Acid Wear
Interventions Drug: Sodium Fluoride
Drug: Potassium nitrate
Enrollment 56
Recruitment Details Participants were recruited at the clinical site.
Pre-assignment Details  
Arm/Group Title Overall
Hide Arm/Group Description This was a 4-way crossover study. Participants brushed with 1.5 g of low relative dentine abrasivity (RDA) gel to foam toothpaste (Toothpaste 1) containing 1450 parts per million (ppm) of fluoride (F) as sodium fluoride (NaF) and 5% weight by weight (w/w) potassium nitrate (KNO3); 1.5 g of medium RDA gel to foam toothpaste (Toothpaste 2) containing 1450 ppm F as NaF and 5% w/w KNO3; 1.5 g of Marketed toothpaste (Toothpaste 3) containing 1450 ppm F as NaF and 5% w/w KNO3; and 1.5 g of placebo toothpaste containing no fluoride but 5% w/w KNO3. There was a washout period of 2 days following each treatment session. In this washout period, participants used a non-fluoridated toothpaste to ensure no carry over effect.
Period Title: Overall Study
Started 56
Received Placebo (No NaF/KNO3)Toothpaste 56 [1]
Received NaF/KNO3 Toothpaste 1 55 [2]
Received NaF/KNO3 Toothpaste 3 54
Received NaF/KNO3 Toothpaste 2 55
Completed 54
Not Completed 2
Reason Not Completed
Lost to Follow-up             1
Withdrawal by Subject             1
[1]
One participant was lost to follow up in study period 1
[2]
One participant withdrew consent in study period 3
Arm/Group Title All Randomized Participants
Hide Arm/Group Description All randomized participants were evaluated for baseline parameters.
Overall Number of Baseline Participants 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants
38.7  (13.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
Female
27
  48.2%
Male
29
  51.8%
1.Primary Outcome
Title Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure
Hide Description Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.
Time Frame Baseline, 4 hours post treatment in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.
Arm/Group Title NaF/KNO3 Toothpaste 1 NaF/KNO3 Toothpaste 2 NaF/KNO3 Toothpaste 3 No Fluoride/KNO3 Toothpaste
Hide Arm/Group Description:
Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
Overall Number of Participants Analyzed 55 54 54 56
Least Squares Mean (Standard Error)
Unit of Measure: Percentage RER
-36.66  (2.824) -36.53  (2.848) -36.98  (2.847) -77.82  (2.799)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF/KNO3 Toothpaste 1, No Fluoride/KNO3 Toothpaste
Comments Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustments made for multiple comparisons as the primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject (random effect).
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 41.15
Confidence Interval (2-Sided) 95%
34.42 to 47.89
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/KNO3 Toothpaste 2, No Fluoride/KNO3 Toothpaste
Comments Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustments made for multiple comparisons as the primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject (random effect).
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 41.28
Confidence Interval (2-Sided) 95%
34.51 to 48.06
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection NaF/KNO3 Toothpaste 3, No Fluoride/KNO3 Toothpaste
Comments Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustments made for multiple comparisons as the primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject (random effect).
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 40.83
Confidence Interval (2-Sided) 95%
34.06 to 47.61
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
2.Primary Outcome
Title Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure
Hide Description SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH 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 SMH recovery 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. A higher percentage values indicate a better outcome.
Time Frame Baseline, 4 hours post treatment in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.
Arm/Group Title NaF/KNO3 Toothpaste 1 NaF/KNO3 Toothpaste 2 NaF/KNO3 Toothpaste 3 No Fluoride/KNO3 Toothpaste
Hide Arm/Group Description:
Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
Participants brushed with a fluoride free toothpaste (0 ppm F) containing only 5% w/w KNO3.
Overall Number of Participants Analyzed 55 54 54 56
Least Squares Mean (Standard Error)
Unit of Measure: Percentage SMH
32.24  (1.469) 32.32  (1.480) 34.53  (1.480) 22.87  (1.457)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF/KNO3 Toothpaste 1, No Fluoride/KNO3 Toothpaste
Comments Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustments made for multiple comparisons as the primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject (random effect).
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 9.36
Confidence Interval (2-Sided) 95%
6.01 to 12.72
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/KNO3 Toothpaste 2, No Fluoride/KNO3 Toothpaste
Comments Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustments made for multiple comparisons as the primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject (random effect).
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 9.45
Confidence Interval (2-Sided) 95%
6.07 to 12.82
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/KNO3 Toothpaste 3, No Fluoride/KNO3 Toothpaste
Comments Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustments made for multiple comparisons as the primary comparison was pre-specified.
Method ANOVA
Comments ANOVA with factors for treatment, study period, and subject (random effect).
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 11.66
Confidence Interval (2-Sided) 95%
8.28 to 15.03
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
3.Other Pre-specified Outcome
Title RER of Enamel Specimens Post 2 Hours of Treatment Exposure
Hide Description Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.
Time Frame Baseline, 2 hours post treatment in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.
Arm/Group Title NaF/KNO3 Toothpaste 1 NaF/KNO3 Toothpaste 2 NaF/KNO3 Toothpaste 3 No Fluoride/KNO3 Toothpaste
Hide Arm/Group Description:
Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
Overall Number of Participants Analyzed 55 54 54 56
Least Squares Mean (Standard Error)
Unit of Measure: % RER
-43.76  (3.182) -43.33  (3.211) -41.88  (3.210) -85.88  (3.154)
4.Other Pre-specified Outcome
Title SMH Recovery of Enamel Specimens Post 2 Hours of Treatment Exposure
Hide Description SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH 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 SMH recovery 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. A higher percentage values indicate a better outcome.
Time Frame Baseline, 2 hours post treatment in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis.
Arm/Group Title NaF/KNO3 Toothpaste 1 NaF/KNO3 Toothpaste 2 NaF/KNO3 Toothpaste 3 No Fluoride/KNO3 Toothpaste
Hide Arm/Group Description:
Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
Participants brushed with a fluoride free toothpaste (0 ppm F) containing only 5% w/w KNO3.
Overall Number of Participants Analyzed 55 54 54 56
Least Squares Mean (Standard Error)
Unit of Measure: Percentage SMH
28.96  (1.600) 28.92  (1.615) 28.30  (1.615) 17.90  (1.585)
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/KNO3 Toothpaste 1 NaF/KNO3 Toothpaste 2 NaF/KNO3 Toothpaste 3 No Fluoride/KNO3 Toothpaste
Hide Arm/Group Description Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 parts per million of fluoride as NaF and 5% w/w KNO3. Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3. Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3. Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
All-Cause Mortality
NaF/KNO3 Toothpaste 1 NaF/KNO3 Toothpaste 2 NaF/KNO3 Toothpaste 3 No Fluoride/KNO3 Toothpaste
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NaF/KNO3 Toothpaste 1 NaF/KNO3 Toothpaste 2 NaF/KNO3 Toothpaste 3 No Fluoride/KNO3 Toothpaste
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%)      0/54 (0.00%)      0/56 (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/KNO3 Toothpaste 1 NaF/KNO3 Toothpaste 2 NaF/KNO3 Toothpaste 3 No Fluoride/KNO3 Toothpaste
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/55 (3.64%)      0/55 (0.00%)      1/54 (1.85%)      2/56 (3.57%)    
Gastrointestinal disorders         
Gingival Pain   1/55 (1.82%)  1 0/55 (0.00%)  0 0/54 (0.00%)  0 0/56 (0.00%)  0
Infections and infestations         
Nasopharyngitis   0/55 (0.00%)  0 0/55 (0.00%)  0 1/54 (1.85%)  1 2/56 (3.57%)  2
Musculoskeletal and connective tissue disorders         
Back Pain   1/55 (1.82%)  1 0/55 (0.00%)  0 0/54 (0.00%)  0 0/56 (0.00%)  0
Indicates events were collected by systematic assessment
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: NCT01657903     History of Changes
Other Study ID Numbers: Z6961385
First Submitted: August 2, 2012
First Posted: August 6, 2012
Results First Submitted: January 16, 2014
Results First Posted: January 26, 2015
Last Update Posted: January 26, 2015