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Trial record 70 of 292 for:    Sodium Fluoride OR Duraphat

In Vivo Investigation of Initial Stages of Enamel 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: NCT02533466
Recruitment Status : Completed
First Posted : August 26, 2015
Results First Posted : June 15, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Basic Science
Condition Tooth Erosion
Interventions Other: Sodium fluoride + potassium nitrate
Other: Potassium nitrate
Enrollment 30
Recruitment Details Participants were recruited at 1 center in United Kingdom.
Pre-assignment Details A total of 30 participants were screened and all of them were randomized.
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water. Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
Period Title: Overall Study
Started 16 14
Completed 16 14
Not Completed 0 0
Arm/Group Title Test Product Reference Product Total
Hide Arm/Group Description Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush and swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water. Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water Total of all reporting groups
Overall Number of Baseline Participants 16 14 30
Hide Baseline Analysis Population Description
The Per Protocol (PP) population was the primary population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 14 participants 30 participants
36.1  (11.17) 38.1  (12.21) 37.1  (11.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Female
4
  25.0%
1
   7.1%
5
  16.7%
Male
12
  75.0%
13
  92.9%
25
  83.3%
1.Primary Outcome
Title Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge
Hide Description

The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.

The Images were graded as follows:

  1. - No signs of surface erosive wear (no evidence of the “lock and key” structure)
  2. - Early signs of erosive surface changes
  3. - Mild signs of erosive surface changes (early signs of the “lock and key” structure).
  4. - Moderate signs of erosive surface changes
  5. - Severe signs of erosive surface changes (“lock and key” structure and enamel “pits”) X - Not evaluable
Time Frame Baseline, 30 minutes post dietary acid challenge
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol (PP) population was defined as those subjects in the ITT (intent to treat) population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
Overall Number of Participants Analyzed 16 14
Median (Full Range)
Unit of Measure: Scores on grading scale
3.75
(0 to 4)
3.17
(0 to 4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product, Reference Product
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalent analyses was executed using scale transformation or non-parametric methods.
Statistical Test of Hypothesis P-Value 0.2673
Comments P-value was calculated from Wilcoxon Rank Sum test.
Method Wilcoxon Rank Sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-1.0 to 0.0
Estimation Comments

Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.

Difference was calculated as reference product minus test product.

2.Secondary Outcome
Title Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge.
Hide Description

The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.

The Images were graded as follows:

  1. - No signs of surface erosive wear (no evidence of the “lock and key” structure)
  2. - Early signs of erosive surface changes
  3. - Mild signs of erosive surface changes (early signs of the “lock and key” structure).
  4. - Moderate signs of erosive surface changes
  5. - Severe signs of erosive surface changes (“lock and key” structure and enamel “pits”) X - Not evaluable
Time Frame Baseline, 2 hours post acid challenge
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
Overall Number of Participants Analyzed 16 14
Median (Full Range)
Unit of Measure: Scores on grading scale
3.83
(0.0 to 4.0)
2.33
(0.0 to 3.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product, Reference Product
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalent analyses was executed using scale transformation or non-parametric methods
Statistical Test of Hypothesis P-Value 0.0690
Comments P-value was calculated from Wilcoxon Rank Sum test.
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.92
Confidence Interval (2-Sided) 95%
-1.8 to 0.0
Estimation Comments

Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.

Difference was calculated as reference product minus test product.

3.Secondary Outcome
Title Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge
Hide Description

The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.

The Images were graded as follows:

  1. - No signs of surface erosive wear (no evidence of the “lock and key” structure)
  2. - Early signs of erosive surface changes
  3. - Mild signs of erosive surface changes (early signs of the “lock and key” structure).
  4. - Moderate signs of erosive surface changes
  5. - Severe signs of erosive surface changes (“lock and key” structure and enamel “pits”) X - Not evaluable
Time Frame Baseline, 4 hours post acid challenge
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
Overall Number of Participants Analyzed 16 14
Median (Full Range)
Unit of Measure: Scores on grading scale
3.17
(0.0 to 4.0)
1.08
(0.0 to 2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product, Reference Product
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalent analyses was executed using scale transformation or non-parametric methods
Statistical Test of Hypothesis P-Value 0.0680
Comments P-value was calculated from Wilcoxon Rank Sum test.
Method Wilcoxon Rank Sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -1.50
Confidence Interval (2-Sided) 95%
-2.7 to 0.0
Estimation Comments

Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.

Difference was calculated as reference product minus test product.

4.Secondary Outcome
Title Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge
Hide Description

The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.

The Images were graded as follows:

  1. - No signs of surface erosive wear (no evidence of the “lock and key” structure)
  2. - Early signs of erosive surface changes
  3. - Mild signs of erosive surface changes (early signs of the “lock and key” structure).
  4. - Moderate signs of erosive surface changes
  5. - Severe signs of erosive surface changes (“lock and key” structure and enamel “pits”) X - Not evaluable
Time Frame Baseline, 7 hours post acid challenge
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
Overall Number of Participants Analyzed 16 14
Median (Full Range)
Unit of Measure: Scores on grading scale
2.58
(0.0 to 4.0)
0.75
(0.0 to 2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product, Reference Product
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalent analyses was executed using scale transformation or non-parametric methods
Statistical Test of Hypothesis P-Value 0.0654
Comments P-value is calculated from Wilcoxon Rank Sum test.
Method Wilcoxon Rank Sum test.
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -1.83
Confidence Interval (2-Sided) 95%
-3.0 to 0.0
Estimation Comments

Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.

Difference was calculated as reference product minus test product

5.Secondary Outcome
Title Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge
Hide Description Saliva stored at 0 - 20°C was used for determining calcium concentration
Time Frame Baseline, 30 mins post dietary acid challenge
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: ppm
-12.81  (9.101) -16.29  (12.041)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product, Reference Product
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalent analyses was executed using scale transformation or non-parametric methods.
Statistical Test of Hypothesis P-Value 0.6061
Comments P value obtained from the ANCOVA analysis
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-6.8 to 4.1
Estimation Comments Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.
6.Secondary Outcome
Title Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge
Hide Description Saliva stored at 0 - 20°C was used for determining calcium concentration
Time Frame Baseline, 7 hours post dietary acid challenge
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: ppm
4.38  (10.308) 0.00  (11.094)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product, Reference Product
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalent analyses was executed using scale transformation or non-parametric methods.
Statistical Test of Hypothesis P-Value 0.4080
Comments P value obtained from the ANCOVA analysis.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-7.9 to 3.3
Estimation Comments Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product
7.Secondary Outcome
Title Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge
Hide Description Saliva stored at 0 - 20°C was used for determining pH
Time Frame Baseline, 30 mins post dietary acid challenge
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: pH units
-0.71  (0.854) -0.51  (0.620)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product, Reference Product
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalent analyses was executed using scale transformation or non-parametric methods.
Statistical Test of Hypothesis P-Value 0.4611
Comments P value obtained from the ANCOVA analysis.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
-0.4 to 0.8
Estimation Comments Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.
8.Secondary Outcome
Title Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge
Hide Description Saliva stored at 0 - 20°C was used for determining pH
Time Frame Baseline, 7 hours post dietary acid challenge
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: pH units
0.00  (0.219) 0.16  (0.569)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product, Reference Product
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalent analyses was executed using scale transformation or non-parametric methods.
Statistical Test of Hypothesis P-Value 0.3939
Comments P value obtained from the ANCOVA analysis.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.1 to 0.3
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge
Hide Description Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.
Time Frame Baseline, 30 mins post dietary acid challenge
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.81  (3.885) -1.50  (3.322)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product, Reference Product
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalent analyses was executed using scale transformation or non-parametric methods.
Statistical Test of Hypothesis P-Value 0.7829
Comments P value obtained from the ANCOVA analysis.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
-2.2 to 2.8
Estimation Comments Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.
10.Secondary Outcome
Title Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge
Hide Description Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.
Time Frame Baseline, 7 hours post dietary acid challenge
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description:
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.25  (2.463) -0.36  (2.706)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product, Reference Product
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalent analyses was executed using scale transformation or non-parametric methods
Statistical Test of Hypothesis P-Value 0.9121
Comments P value obtained from the ANCOVA analysis.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-1.6 to 1.4
Estimation Comments Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.
Time Frame Baseline upto Day 2
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Product Reference Product
Hide Arm/Group Description Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water. Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
All-Cause Mortality
Test Product Reference Product
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Test Product Reference Product
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (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 Reference Product
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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: NCT02533466     History of Changes
Other Study ID Numbers: 204739
First Submitted: August 24, 2015
First Posted: August 26, 2015
Results First Submitted: July 6, 2016
Results First Posted: June 15, 2017
Last Update Posted: August 2, 2017