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Trial record 9 of 33 for:    FLUORIDE ION AND NITRATE ION

A Test on a New Experimental Mouth Rinse for Relieving Tooth Sensitivity

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ClinicalTrials.gov Identifier: NCT01727258
Recruitment Status : Completed
First Posted : November 15, 2012
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: Single (Investigator)
Condition Dentin Sensitivity
Interventions Device: Mouth Rinse
Drug: Fluoride Toothpaste
Drug: Potassium Nitrate Toothpaste
Enrollment 153
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Colgate Regular Sensodyne Toothpaste Potassium Oxalate Mouthrinse
Hide Arm/Group Description Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007). 5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046). Potassium Oxalate Mouthrinse (experimental group)(12027-033).
Period Title: Overall Study
Started 51 51 51
Completed 49 48 50
Not Completed 2 3 1
Reason Not Completed
Adverse Event             0             2             0
Noncompliance with Study Drug             0             0             1
Withdrawal by Subject             1             1             0
Lost to Follow-up             1             0             0
Arm/Group Title Colgate Regular Sensodyne Toothpaste Potassium Oxalate Mouthrinse Total
Hide Arm/Group Description Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007). 5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046). Potassium Oxalate Mouthrinse (experimental group)(12027-033). Total of all reporting groups
Overall Number of Baseline Participants 51 51 51 153
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 51 participants 51 participants 153 participants
38.4  (10.97) 37.0  (11.56) 39.9  (10.46) 38.4  (11.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 51 participants 153 participants
Female
33
  64.7%
37
  72.5%
39
  76.5%
109
  71.2%
Male
18
  35.3%
14
  27.5%
12
  23.5%
44
  28.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
USA Number Analyzed 51 participants 51 participants 51 participants 153 participants
51 51 51 153
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 Colgate Regular Sensodyne Toothpaste Potassium Oxalate Mouthrinse
Hide Arm/Group Description:
Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
Potassium Oxalate Mouthrinse (experimental group)(12027-033)
Overall Number of Participants Analyzed 49 48 50
Least Squares Mean (Standard Error)
Unit of Measure: grams of force
11.21  (1.221) 23.81  (1.234) 22.07  (1.210)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Colgate Regular, Potassium Oxalate Mouthrinse
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 Mouthrinse is better than Colgate Regular (p<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouthrinse and Colgate 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 10.85
Confidence Interval (2-Sided) 95%
7.45 to 14.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.720
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sensodyne Toothpaste, Potassium Oxalate Mouthrinse
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 0.314
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 (Yeaple probe) score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.74
Confidence Interval (2-Sided) 95%
-5.16 to 1.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.729
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Colgate Regular, 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 (Yeaple probe) score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.60
Confidence Interval (2-Sided) 95%
9.17 to 16.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.735
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 Colgate Regular Sensodyne Toothpaste Potassium Oxalate Mouthrinse
Hide Arm/Group Description:
Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
Potassium Oxalate Mouthrinse (experimental group)(12027-033)
Overall Number of Participants Analyzed 50 49 50
Least Squares Mean (Standard Error)
Unit of Measure: grams of force
11.09  (0.832) 17.00  (0.840) 17.18  (0.832)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Colgate Regular, Potassium Oxalate Mouthrinse
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 Mouthrinse is better than Colgate Regular (p<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouthrinse and Sensodyne. 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 6.08
Confidence Interval (2-Sided) 95%
3.76 to 8.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.177
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sensodyne Toothpaste, Potassium Oxalate Mouthrinse
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 0.881
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 0.18
Confidence Interval (2-Sided) 95%
-2.16 to 2.52
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.183
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Colgate Regular, 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 Significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
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 5.91
Confidence Interval (2-Sided) 95%
3.57 to 8.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.182
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Tactile Sensitivity VAS Score at Week 2
Hide Description Tooth sensitivity was measured using a Visual Analogue Scale (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 Colgate Regular Sensodyne Toothpaste Potassium Oxalate Mouthrinse
Hide Arm/Group Description:
Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
Potassium Oxalate Mouthrinse (experimental group)(12027-033)
Overall Number of Participants Analyzed 50 49 50
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale (mm)
43.80  (2.009) 36.95  (2.020) 37.08  (2.017)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Colgate Regular, Potassium Oxalate Mouthrinse
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 0.020
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 -6.72
Confidence Interval (2-Sided) 95%
-12.38 to -1.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.866
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sensodyne Toothpaste, Potassium Oxalate Mouthrinse
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 0.964
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 0.13
Confidence Interval (2-Sided) 95%
-5.52 to 5.78
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.860
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Colgate Regular, 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 0.017
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 -6.85
Confidence Interval (2-Sided) 95%
-12.47 to -1.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.845
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Tactile Sensitivity VAS Score at Week 4
Hide Description Tooth sensitivity was measured using a Visual Analogue Scale (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 Colgate Regular Sensodyne Toothpaste Potassium Oxalate Mouthrinse
Hide Arm/Group Description:
Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
Potassium Oxalate Mouthrinse (experimental group)(12027-033)
Overall Number of Participants Analyzed 49 48 50
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale (mm)
38.38  (2.342) 26.40  (2.353) 31.45  (2.327)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Colgate Regular, Potassium Oxalate Mouthrinse
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 0.039
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 -6.92
Confidence Interval (2-Sided) 95%
-13.50 to -0.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.327
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sensodyne Toothpaste, Potassium Oxalate Mouthrinse
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 0.130
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 5.06
Confidence Interval (2-Sided) 95%
-1.50 to 11.61
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.317
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Colgate Regular, 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 -11.98
Confidence Interval (2-Sided) 95%
-18.53 to -5.43
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.313
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 Visual Analogue Scale (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 Colgate Regular Sensodyne Toothpaste Potassium Oxalate Mouthrinse
Hide Arm/Group Description:
Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
Potassium Oxalate Mouthrinse (experimental group)(12027-033)
Overall Number of Participants Analyzed 50 49 50
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale (mm)
45.41  (2.233) 32.89  (2.246) 37.15  (2.227)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Colgate Regular, Potassium Oxalate Mouthrinse
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 air stimulus VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.26
Confidence Interval (2-Sided) 95%
-14.51 to -2.00
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.163
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sensodyne Toothpaste, Potassium Oxalate Mouthrinse
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 0.179
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method ANCOVA
Comments Terms included treatment and baseline mean air stimulus VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.26
Confidence Interval (2-Sided) 95%
-1.98 to 10.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.160
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Colgate Regular, 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 air stimulus VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.52
Confidence Interval (2-Sided) 95%
-18.79 to -6.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.172
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 Visual Analogue Scale (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 Colgate Regular Sensodyne Toothpaste Potassium Oxalate Mouthrinse
Hide Arm/Group Description:
Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
Potassium Oxalate Mouthrinse (experimental group)(12027-033)
Overall Number of Participants Analyzed 49 48 50
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale (mm)
42.03  (2.511) 24.56  (2.524) 30.10  (2.479)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Colgate Regular, Potassium Oxalate Mouthrinse
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 air stimulus VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.93
Confidence Interval (2-Sided) 95%
-18.93 to -4.93
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.543
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sensodyne Toothpaste, Potassium Oxalate Mouthrinse
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 0.119
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method ANCOVA
Comments Terms included treatment and baseline mean air stimulus VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.54
Confidence Interval (2-Sided) 95%
-1.44 to 12.53
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.534
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Colgate Regular, 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 air stimulus VAS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.47
Confidence Interval (2-Sided) 95%
-24.52 to -10.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.566
Estimation Comments [Not Specified]
Time Frame Day 28 -2 days/+4 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 -2 days/+4 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 Colgate Regular Sensodyne Toothpaste Potassium Oxalate Mouthrinse
Hide Arm/Group Description Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007). 5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046). Potassium Oxalate Mouthrinse (experimental group)(12027-033).
All-Cause Mortality
Colgate Regular Sensodyne Toothpaste Potassium Oxalate Mouthrinse
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Colgate Regular Sensodyne Toothpaste Potassium Oxalate Mouthrinse
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/51 (0.00%)   0/51 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Colgate Regular Sensodyne Toothpaste Potassium Oxalate Mouthrinse
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/51 (0.00%)   0/51 (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: NCT01727258     History of Changes
Other Study ID Numbers: KOXDHY0008
First Submitted: November 12, 2012
First Posted: November 15, 2012
Results First Submitted: May 20, 2015
Results First Posted: June 10, 2015
Last Update Posted: June 10, 2015