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Trial record 100 of 292 for:    Sodium Fluoride OR Duraphat

In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste

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: NCT03296072
Recruitment Status : Completed
First Posted : September 28, 2017
Results First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Tooth Erosion
Interventions Drug: 0.254% w/w sodium fluoride and 5% KNO3
Drug: 0.454% w/w stannous fluoride
Drug: 5% KNO3
Enrollment 62
Recruitment Details Participants were recruited from one center in United States of America.
Pre-assignment Details A total of 68 participates were screened, out of which 62 participants were randomized in the study and 6 participants were not randomized as all the 6 participants did not meet study criteria.
Arm/Group Title Test Product/Comparator Product/Placebo Product Test Product/Placebo Product/Comparator Product Comparator Product/Test Product/Placebo Product Comparator Product/Placebo Product/ Test Product Placebo Product/Test Product/Comparator Product Placebo Product/Comparator Product/Test Product
Hide Arm/Group Description Participants in this arm received test product (0.254% weight by weight [w/w] sodium fluoride [NaF; 1150 parts per million {ppm} fluoride] and 5% potassium nitrate [KNO3]) followed by comparator (0.454% w/w stannous fluoride [SnF2; 1100 ppm fluoride]) and placebo product (5% KNO3 [0 ppm fluoride]) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 grams [g]) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing,for a timed period of 95 seconds. After expectorating the slurry, participants gently rinsed their mouths with 15 milliliters [mL] of tap water for 10 seconds before expectorating again. Participants in this arm received test product (0.254% w/w NaF [1150 ppm fluoride] and 5% KNO3) followed by placebo (5% KNO3 [0 ppm fluoride])and comparator product (0.454% w/w SnF2[1100 ppm fluoride]) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 g) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants gently rinsed their mouths with 15 mL of tap water for 10 seconds before expectorating again. Participants in this arm received comparator product (0.454% w/w SnF2[1100 ppm fluoride]) followed by test (0.254% w/w NaF [1150 ppm fluoride] and 5% KNO3) and placebo product(5% KNO3 [0 ppm fluoride]) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 g) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants gently rinsed their mouths with 15 mL of tap water for 10 seconds before expectorating again. Participants in this arm received comparator product (0.454% w/w SnF2[1100 ppm fluoride]) followed by placebo (5% KNO3 [0 ppm fluoride])and test product (0.254% w/w NaF [1150 ppm fluoride] and 5% KNO3) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 g) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants gently rinsed their mouths with 15 mL of tap water for 10 seconds before expectorating again. Participants in this arm received placebo product (5% KNO3 [0 ppm fluoride]) followed by test (0.254% w/w NaF [1150 ppm fluoride] and 5% KNO3) and comparator product (0.454% w/w SnF2 [1100 ppm fluoride]) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 g) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants gently rinsed their mouths with 15 mL of tap water for 10 seconds before expectorating again. Participants in this arm received placebo product (5% KNO3 [0 ppm fluoride]) followed by comparator (0.454% w/w SnF2[1100 ppm fluoride]) and test product (0.254% w/w NaF [1150 ppm fluoride] and 5% KNO3) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 g) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants gently rinsed their mouths with 15 mL of tap water for 10 seconds before expectorating again.
Period Title: Treatment Period 1
Started 10 11 10 10 10 11
Completed 10 11 10 10 10 11
Not Completed 0 0 0 0 0 0
Period Title: Treament Period 1: Wash Out Period
Started 10 11 10 10 10 11
Completed 10 11 10 10 10 11
Not Completed 0 0 0 0 0 0
Period Title: Treament Period 2
Started 10 11 10 10 10 11
Completed 10 11 10 10 10 11
Not Completed 0 0 0 0 0 0
Period Title: Treament Period 2: Wash Out Period
Started 10 11 10 10 10 11
Completed 10 11 10 10 10 11
Not Completed 0 0 0 0 0 0
Period Title: Treament Period 3
Started 10 11 10 10 10 11
Completed 10 11 10 10 10 11
Not Completed 0 0 0 0 0 0
Arm/Group Title Overall Participants
Hide Arm/Group Description All randomized participants were included for baseline evaluation. Participants applied a full ribbon of the test (0.254% w/w NaF [1150 ppm fluoride] and 5% KNO3), comparator (0.454% w/w SnF2[1100 ppm fluoride]) and placebo product (5% KNO3 [0 ppm fluoride]) and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, participants gently rinsed with 15 mL of tap water for 10 seconds before expectorating again.
Overall Number of Baseline Participants 62
Hide Baseline Analysis Population Description
Safety Population included all randomized participants who received at least 1 dose of study treatment. This population was based on the treatment the participant actually received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants
43.4  (13.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants
Female
45
  72.6%
Male
17
  27.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants
Hispanic or Latino
4
   6.5%
Not Hispanic or Latino
58
  93.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants
American Indian or Alaska Native
0
   0.0%
Asian
5
   8.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
14
  22.6%
White
42
  67.7%
More than one race
1
   1.6%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title % Surface Micro Hardness Recovery (SMHR; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Enhance Remineralization of Enamel)
Hide Description The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR was calculated as : %SMHR = [(E1−R)/(E1−B)]*100. Greater values of %SMHR indicate that greater remineralization has occurred, thus higher values are more favorable.
Time Frame After 4 hrs following single exposure of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
Arm/Group Title Test Product Placebo Product
Hide Arm/Group Description:
Participants applied a full ribbon of the test product (1.5 g) containing 0.254% w/w NaF (1150 ppm fluoride) and 5% KNO3 and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
Participants applied a full ribbon of the placebo (1.5 g) containing 5% KNO3 (0 ppm fluoride) and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
Overall Number of Participants Analyzed 62 62
Least Squares Mean (Standard Error)
Unit of Measure: Percentage SMHR
29.67  (1.12) 21.98  (1.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product, Placebo Product
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments From ANOVA with fixed factors for study period and treatment, and a random effect for participant.
Method of Estimation Estimation Parameter Difference of Least Square mean
Estimated Value 7.69
Confidence Interval (2-Sided) 95%
5.18 to 10.19
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 % Relative Erosion Resistance (RER; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Inhibit Demineralization of Enamel)
Hide Description The %RER was calculated to assess the ability of treated enamel specimens to provide a combined benefit in terms of enhanced remineralization and acid resistance of the enamel. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after the second erosive challenge (E2) (E2 is measured for after both 2 and 4 hours of remineralization). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %RER was calculated as : %RER = [(E1-E2)/ (E1-B)]*100. Higher values of %RER indicate greater resistance to erosion, thus higher values are more favorable.
Time Frame After 4 hrs following single exposure of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
Arm/Group Title Test Product Placebo Product
Hide Arm/Group Description:
Participants applied a full ribbon of the test product (1.5 g) containing 0.254% w/w NaF (1150 ppm fluoride) and 5% KNO3 and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
Participants applied a full ribbon of the placebo (1.5 g) containing 5% KNO3 (0 ppm fluoride) and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
Overall Number of Participants Analyzed 62 62
Least Squares Mean (Standard Error)
Unit of Measure: Percentage RER
-23.65  (1.96) -56.94  (1.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product, Placebo Product
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments From ANOVA with fixed factors for study period and treatment, and a random effect for participant.
Method of Estimation Estimation Parameter Difference of Least Square mean
Estimated Value 33.29
Confidence Interval (2-Sided) 95%
28.89 to 37.68
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 Enamel Fluoride Uptake (EFU; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Promote Fluoride Uptake in Enamel)
Hide Description The EFU was measured to determine the amount of fluoride incorporation into the model erosive lesions. Each enamel specimen drilled to a depth of approximately 100 μm using a microdrill, through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then, dissolved in a known volume of perchloric acid and immediately analyzed for fluoride content using a calibrated fluoride specific electrode. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram fluoride per square centimeter (μgF/cm^2). Higher values of EFU indicate greater incorporation of fluoride into the enamel and are thus more favorable.
Time Frame After 4 hrs following single exposure of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
Arm/Group Title Test Product Placebo Product
Hide Arm/Group Description:
Participants applied a full ribbon of the test product (1.5 g) containing 0.254% w/w NaF (1150 ppm fluoride) and 5% KNO3 and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
Participants applied a full ribbon of the placebo (1.5 g) containing 5% KNO3 (0 ppm fluoride) and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
Overall Number of Participants Analyzed 62 62
Least Squares Mean (Standard Error)
Unit of Measure: Microgram fluoride per square centimeter
2.98  (0.09) 1.17  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product, Placebo Product
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments From ANOVA with fixed factors for study period and treatment, and a random effect for participant.
Method of Estimation Estimation Parameter Difference of Least Square mean
Estimated Value 1.81
Confidence Interval (2-Sided) 95%
1.59 to 2.04
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 % SMHR (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
Hide Description The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR was calculated as: %SMHR = [(E1−R)/(E1−B)]*100. Greater values of %SMHR indicate that greater remineralization has occurred, thus higher values are more favorable.
Time Frame After 4 hrs following single exposure of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
Arm/Group Title Test Product Comparator Product
Hide Arm/Group Description:
Participants applied a full ribbon of the test product (1.5 g) containing 0.254% w/w NaF (1150 ppm fluoride) and 5% KNO3 and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
Participants applied a full ribbon of the placebo (1.5 g) containing 0.454% w/w SnF2 (1100 ppm fluoride) and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
Overall Number of Participants Analyzed 62 62
Least Squares Mean (Standard Error)
Unit of Measure: Percentage SMHR
29.67  (1.12) 22.10  (1.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product, Comparator Product
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments From ANOVA with fixed factors for study period and treatment, and a random effect for participant.
Method of Estimation Estimation Parameter Difference of Least Square mean
Estimated Value 7.57
Confidence Interval (2-Sided) 95%
5.07 to 11.07
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 % RER (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
Hide Description The %RER was calculated to assess the ability of treated enamel specimens to provide a combined benefit in terms of enhanced remineralization and acid resistance of the enamel. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after the second erosive challenge (E2) (E2 is measured for after both 2 and 4 hours of remineralization). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %RER was calculated as : %RER = [(E1-E2)/ (E1-B)]*100. Higher values of %RER indicate greater resistance to erosion, thus higher values are more favorable.
Time Frame After 4 hrs following single exposure of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
Arm/Group Title Test Product Comparator Product
Hide Arm/Group Description:
Participants applied a full ribbon of the test product (1.5 g) containing 0.254% w/w NaF (1150 ppm fluoride) and 5% KNO3 and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
Participants applied a full ribbon of the placebo (1.5 g) containing 0.454% w/w SnF2 (1100 ppm fluoride) and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
Overall Number of Participants Analyzed 62 62
Least Squares Mean (Standard Error)
Unit of Measure: Percentage RER
-23.65  (1.96) -34.63  (1.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product, Comparator Product
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments From ANOVA with fixed factors for study period and treatment, and a random effect for participant.
Method of Estimation Estimation Parameter Difference of Least Square mean
Estimated Value 10.98
Confidence Interval (2-Sided) 95%
6.58 to 15.37
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 EFU (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
Hide Description The EFU was measured to determine the amount of fluoride incorporation into the model erosive lesions. Each enamel specimen drilled to a depth of approximately 100 μm using a microdrill, through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then, dissolved in a known volume of perchloric acid and immediately analyzed for fluoride content using a calibrated fluoride specific electrode. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram fluoride per square centimeter (μgF/cm^2). Higher values of EFU indicate greater incorporation of fluoride into the enamel and are thus more favorable.
Time Frame After 4 hrs following single exposure of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
Arm/Group Title Test Product Comparator Product
Hide Arm/Group Description:
Participants applied a full ribbon of the test product (1.5 g) containing 0.254% w/w NaF (1150 ppm fluoride) and 5% KNO3 and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
Participants applied a full ribbon of the placebo (1.5 g) containing 0.454% w/w SnF2 (1100 ppm fluoride) and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
Overall Number of Participants Analyzed 62 62
Least Squares Mean (Standard Error)
Unit of Measure: Microgram fluoride per square centimeter
2.98  (0.09) 2.01  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product, Comparator Product
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments From ANOVA with fixed factors for study period and treatment, and a random effect for participant.
Method of Estimation Estimation Parameter Difference of Least Square mean
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.75 to 1.20
Estimation Comments Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.
Time Frame 4 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Product Comparator Product Placebo Product
Hide Arm/Group Description Participants applied a full ribbon of the test product (1.5 g) containing 0.254% w/w NaF (1150 ppm fluoride) and 5% KNO3 and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again. Participants applied a full ribbon of the placebo (1.5 g) containing 0.454% w/w SnF2 (1100 ppm fluoride) and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again. Participants applied a full ribbon of the placebo (1.5 g) containing 5% KNO3 (0 ppm fluoride) and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth for 95 timed seconds. After expectorating the slurry, participants gently rinsed their mouth with 15 mL of tap water for 10 seconds before expectorating again.
All-Cause Mortality
Test Product Comparator Product Placebo Product
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)      0/62 (0.00%)      0/62 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Test Product Comparator Product Placebo Product
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/62 (0.00%)      0/62 (0.00%)      0/62 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Test Product Comparator Product Placebo Product
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/62 (12.90%)      6/62 (9.68%)      10/62 (16.13%)    
Gastrointestinal disorders       
Dental caries   0/62 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1
Lip haematoma   1/62 (1.61%)  1 0/62 (0.00%)  0 0/62 (0.00%)  0
Mouth ulceration   0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Oral Discomfort   0/62 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1
Oral Mucosal Erthyema   2/62 (3.23%)  2 0/62 (0.00%)  0 1/62 (1.61%)  1
Oral Pain   0/62 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1
Toothache   1/62 (1.61%)  1 0/62 (0.00%)  0 1/62 (1.61%)  1
Infections and infestations       
Bronchitis   0/62 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1
Gastrointestinal Bactetial Overgrowth   0/62 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1
Herpes Zoster   0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Nasopharyngitis   2/62 (3.23%)  2 1/62 (1.61%)  1 0/62 (0.00%)  0
Sinusistis   1/62 (1.61%)  1 0/62 (0.00%)  0 0/62 (0.00%)  0
Urinary Tract Infection   1/62 (1.61%)  1 0/62 (0.00%)  0 0/62 (0.00%)  0
Injury, poisoning and procedural complications       
Arthopod Bite   0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Burn Oral Cavity   0/62 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1
Contusion   0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Joint Dislocation   0/62 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1
Palate Injury   0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Tooth Fracture   0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Traumatic Ulcer   1/62 (1.61%)  1 0/62 (0.00%)  0 0/62 (0.00%)  0
Mouth Injury   0/62 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1
Nervous system disorders       
Periodic limb movement disorder   0/62 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1
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.
 
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343 Ext:
EMail: GSKClinicalSupportHD@gsk.com
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03296072     History of Changes
Other Study ID Numbers: 208166
First Submitted: September 25, 2017
First Posted: September 28, 2017
Results First Submitted: January 3, 2019
Results First Posted: February 20, 2019
Last Update Posted: February 20, 2019