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Trial record 17 of 32 for:    FLUORIDE ION AND NITRATE ION

A Study of the Relief of Tooth Sensitivity of an Experimental Mouthrinse Device

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: NCT01345292
Recruitment Status : Completed
First Posted : May 2, 2011
Results First Posted : June 10, 2015
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Dentin Sensitivity
Interventions Device: Mouthwash
Drug: Potassium nitrate toothpaste
Drug: Sodium fluoride toothpaste
Enrollment 226
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Negative Control (Crest Regular Toothpaste) Positive Control (Sensodyne Toothpaste) 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Hide Arm/Group Description Crest® Cavity Protection Regular Toothpaste (Brushing Only) Sensodyne® Original Toothpaste (Brushing Only) Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
Period Title: Overall Study
Started 75 76 75
Completed 73 76 74
Not Completed 2 0 1
Reason Not Completed
Withdrawal by Subject             2             0             1
Arm/Group Title Negative Control (Crest Regular Toothpaste) Positive Control (Sensodyne Toothpaste) 12027-027 (1.40% Potassium Oxalate Mouth Rinse) Total
Hide Arm/Group Description Crest® Cavity Protection Regular Toothpaste (Brushing Only) Sensodyne® Original Toothpaste (Brushing Only) Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse) Total of all reporting groups
Overall Number of Baseline Participants 75 76 75 226
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 76 participants 75 participants 226 participants
35.6  (10.65) 35.8  (12.14) 37.4  (11.10) 36.3  (11.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 76 participants 75 participants 226 participants
Female
51
  68.0%
52
  68.4%
50
  66.7%
153
  67.7%
Male
24
  32.0%
24
  31.6%
25
  33.3%
73
  32.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
USA Number Analyzed 75 participants 76 participants 75 participants 226 participants
75 76 75 226
1.Primary Outcome
Title Mean Tactile Sensitivity Score at Week 4
Hide Description Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Negative Control (Crest Regular Toothpaste) Positive Control (Sensodyne Toothpaste) 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Sensodyne® Original Toothpaste (Brushing Only)
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 73 76 74
Least Squares Mean (Standard Error)
Unit of Measure: grams of force
10.39  (1.111) 21.83  (1.086) 18.72  (1.101)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control (Crest Regular Toothpaste), Positive Control (Sensodyne Toothpaste)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If Sensodyne is better than Crest Regular (p<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Sensodyne and Crest Regular. Family-wise error was controlled at 0.05.
Method ANCOVA
Comments Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.44
Confidence Interval (2-Sided) 95%
8.37 to 14.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.556
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control (Crest Regular Toothpaste), 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If Potassium Oxalate Mouth Rinse is better than Crest Regular (p<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouth Rinse and Crest Regular. Family-wise error was controlled at 0.05.
Method ANCOVA
Comments Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.33
Confidence Interval (2-Sided) 95%
5.24 to 11.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.566
Estimation Comments [Not Specified]
2.Primary Outcome
Title Mean Tactile Sensitivity Score at Week 2
Hide Description Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Negative Control (Crest Regular Toothpaste) Positive Control (Sensodyne Toothpaste) 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Sensodyne® Original Toothpaste (Brushing Only)
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 75 76 74
Least Squares Mean (Standard Error)
Unit of Measure: grams of force
10.10  (0.576) 13.16  (0.571) 12.51  (0.579)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control (Crest Regular Toothpaste), Positive Control (Sensodyne Toothpaste)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.
Method ANCOVA
Comments Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.05
Confidence Interval (2-Sided) 95%
1.45 to 4.65
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.812
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control (Crest Regular Toothpaste), 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.
Method ANCOVA
Comments Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.41
Confidence Interval (2-Sided) 95%
0.80 to 4.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.818
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Tactile Sensitivity Visual Analog Scale (VAS) Score at Week 2
Hide Description Tooth sensitivity was measured using a VAS. At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Negative Control (Crest Regular Toothpaste) Positive Control (Sensodyne Toothpaste) 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Sensodyne® Original Toothpaste (Brushing Only)
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 75 76 74
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale (mm)
41.59  (1.478) 39.52  (1.471) 37.16  (1.485)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control (Crest Regular Toothpaste), Positive Control (Sensodyne Toothpaste)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.324
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method ANCOVA
Comments Terms included treatment and baseline mean tactile sensitivity VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.06
Confidence Interval (2-Sided) 95%
-6.19 to 2.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.091
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control (Crest Regular Toothpaste), 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method ANCOVA
Comments Terms included treatment and baseline mean tactile sensitivity VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.43
Confidence Interval (2-Sided) 95%
-8.56 to -0.31
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.093
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Tactile Sensitivity VAS Score at Week 4
Hide Description Tooth sensitivity was measured using a VAS. At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Negative Control (Crest Regular Toothpaste) Positive Control (Sensodyne Toothpaste) 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Sensodyne® Original Toothpaste (Brushing Only)
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 73 76 74
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale (mm)
39.49  (1.815) 30.94  (1.782) 29.32  (1.799)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control (Crest Regular Toothpaste), Positive Control (Sensodyne Toothpaste)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method ANCOVA
Comments Terms included treatment and baseline mean tactile sensitivity VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.55
Confidence Interval (2-Sided) 95%
-13.6 to -3.52
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.551
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control (Crest Regular Toothpaste), 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method ANCOVA
Comments Terms included treatment and baseline mean tactile sensitivity VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.2
Confidence Interval (2-Sided) 95%
-15.2 to -5.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.553
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Cold Air Stimulus VAS Score at Week 2
Hide Description Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Negative Control (Crest Regular Toothpaste) Positive Control (Sensodyne Toothpaste) 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Sensodyne® Original Toothpaste (Brushing Only)
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 75 76 74
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale (mm)
43.65  (1.612) 38.74  (1.600) 40.22  (1.623)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control (Crest Regular Toothpaste), Positive Control (Sensodyne Toothpaste)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method ANCOVA
Comments Terms included treatment and baseline mean cold air stimulus VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.91
Confidence Interval (2-Sided) 95%
-9.38 to -0.43
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.271
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control (Crest Regular Toothpaste), 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.136
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method ANCOVA
Comments Terms included treatment and baseline mean cold air stimulus VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.42
Confidence Interval (2-Sided) 95%
-7.93 to 1.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.288
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Mean Cold Air Stimulus VAS Score at Week 4
Hide Description Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Negative Control (Crest Regular Toothpaste) Positive Control (Sensodyne Toothpaste) 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Sensodyne® Original Toothpaste (Brushing Only)
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 73 76 74
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale (mm)
39.54  (1.792) 28.36  (1.755) 29.30  (1.780)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control (Crest Regular Toothpaste), Positive Control (Sensodyne Toothpaste)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method ANCOVA
Comments Terms included treatment and baseline mean cold air stimulus VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.2
Confidence Interval (2-Sided) 95%
-16.1 to -6.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.508
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control (Crest Regular Toothpaste), 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method ANCOVA
Comments Terms included treatment and baseline mean cold air stimulus VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.2
Confidence Interval (2-Sided) 95%
-15.2 to -5.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.527
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Global Subjective VAS Score at Week 2
Hide Description At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: "Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product." The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Negative Control (Crest Regular Toothpaste) Positive Control (Sensodyne Toothpaste) 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Sensodyne® Original Toothpaste (Brushing Only)
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 75 76 74
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale (mm)
44.94  (1.426) 43.68  (1.416) 43.64  (1.434)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control (Crest Regular Toothpaste), Positive Control (Sensodyne Toothpaste)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.533
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method ANCOVA
Comments Terms included treatment and baseline mean global subjective VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.26
Confidence Interval (2-Sided) 95%
-5.22 to 2.71
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.012
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control (Crest Regular Toothpaste), 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.522
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method ANCOVA
Comments Terms included treatment and baseline mean global subjective VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.30
Confidence Interval (2-Sided) 95%
-5.29 to 2.69
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.023
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Global Subjective VAS Score at Week 4
Hide Description At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: "Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product." The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Negative Control (Crest Regular Toothpaste) Positive Control (Sensodyne Toothpaste) 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Hide Arm/Group Description:
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
Sensodyne® Original Toothpaste (Brushing Only)
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
Overall Number of Participants Analyzed 73 76 74
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale (mm)
41.32  (1.664) 32.79  (1.630) 35.19  (1.651)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control (Crest Regular Toothpaste), Positive Control (Sensodyne Toothpaste)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method ANCOVA
Comments Terms included treatment and baseline mean global subjective VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.53
Confidence Interval (2-Sided) 95%
-13.1 to -3.94
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.331
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control (Crest Regular Toothpaste), 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method ANCOVA
Comments Terms included treatment and baseline mean global subjective VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.13
Confidence Interval (2-Sided) 95%
-10.8 to -1.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.344
Estimation Comments [Not Specified]
Time Frame Day 28 ±3 days, +30 days for serious adverse events.
Adverse Event Reporting Description Adverse events were systematically collected at each study visit through Visit 4 (Day 28 ±3 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
 
Arm/Group Title Negative Control (Crest Regular Toothpaste) Positive Control (Sensodyne Toothpaste) 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Hide Arm/Group Description Crest® Cavity Protection Regular Toothpaste (Brushing Only) Sensodyne® Original Toothpaste (Brushing Only) Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
All-Cause Mortality
Negative Control (Crest Regular Toothpaste) Positive Control (Sensodyne Toothpaste) 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Negative Control (Crest Regular Toothpaste) Positive Control (Sensodyne Toothpaste) 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   0/76 (0.00%)   0/75 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Negative Control (Crest Regular Toothpaste) Positive Control (Sensodyne Toothpaste) 12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   0/76 (0.00%)   0/75 (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.
Principal investigator agreed not to publish the study results without prior sponsor approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Lynch, DMD, PhD/Study Director
Organization: Johnson & Johnson Consumer and Personal Products Worldwide
Phone: 908-433-6423 USA EST
EMail: mlynch23@its.jnj.com
Layout table for additonal information
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT01345292     History of Changes
Other Study ID Numbers: KOXDHY0005
First Submitted: April 28, 2011
First Posted: May 2, 2011
Results First Submitted: May 20, 2015
Results First Posted: June 10, 2015
Last Update Posted: June 10, 2015