Trial Outcomes & Findings for A Study of the Relief of Tooth Sensitivity of an Experimental Mouthrinse Device (NCT NCT01345292)
NCT ID: NCT01345292
Last Updated: 2015-06-10
Results Overview
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.
COMPLETED
NA
226 participants
4 weeks
2015-06-10
Participant Flow
Participant milestones
| Measure |
Negative Control (Crest Regular Toothpaste)
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
|
Positive Control (Sensodyne Toothpaste)
Sensodyne® Original Toothpaste (Brushing Only)
|
12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
76
|
75
|
|
Overall Study
COMPLETED
|
73
|
76
|
74
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
Negative Control (Crest Regular Toothpaste)
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
|
Positive Control (Sensodyne Toothpaste)
Sensodyne® Original Toothpaste (Brushing Only)
|
12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
Baseline Characteristics
A Study of the Relief of Tooth Sensitivity of an Experimental Mouthrinse Device
Baseline characteristics by cohort
| Measure |
Negative Control (Crest Regular Toothpaste)
n=75 Participants
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
|
Positive Control (Sensodyne Toothpaste)
n=76 Participants
Sensodyne® Original Toothpaste (Brushing Only)
|
12027-027 (1.40% Potassium Oxalate Mouth Rinse)
n=75 Participants
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 10.65 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 12.14 • n=7 Participants
|
37.4 years
STANDARD_DEVIATION 11.10 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 11.30 • n=4 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Region of Enrollment
USA
|
75 participants
n=5 Participants
|
76 participants
n=7 Participants
|
75 participants
n=5 Participants
|
226 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Negative Control (Crest Regular Toothpaste)
n=73 Participants
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
|
Positive Control (Sensodyne Toothpaste)
n=76 Participants
Sensodyne® Original Toothpaste (Brushing Only)
|
12027-027 (1.40% Potassium Oxalate Mouth Rinse)
n=74 Participants
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
|
|---|---|---|---|
|
Mean Tactile Sensitivity Score at Week 4
|
10.39 grams of force
Standard Error 1.111
|
21.83 grams of force
Standard Error 1.086
|
18.72 grams of force
Standard Error 1.101
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Negative Control (Crest Regular Toothpaste)
n=75 Participants
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
|
Positive Control (Sensodyne Toothpaste)
n=76 Participants
Sensodyne® Original Toothpaste (Brushing Only)
|
12027-027 (1.40% Potassium Oxalate Mouth Rinse)
n=74 Participants
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
|
|---|---|---|---|
|
Mean Tactile Sensitivity Score at Week 2
|
10.10 grams of force
Standard Error 0.576
|
13.16 grams of force
Standard Error 0.571
|
12.51 grams of force
Standard Error 0.579
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Negative Control (Crest Regular Toothpaste)
n=75 Participants
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
|
Positive Control (Sensodyne Toothpaste)
n=76 Participants
Sensodyne® Original Toothpaste (Brushing Only)
|
12027-027 (1.40% Potassium Oxalate Mouth Rinse)
n=74 Participants
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
|
|---|---|---|---|
|
Mean Tactile Sensitivity Visual Analog Scale (VAS) Score at Week 2
|
41.59 units on a scale (mm)
Standard Error 1.478
|
39.52 units on a scale (mm)
Standard Error 1.471
|
37.16 units on a scale (mm)
Standard Error 1.485
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Negative Control (Crest Regular Toothpaste)
n=73 Participants
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
|
Positive Control (Sensodyne Toothpaste)
n=76 Participants
Sensodyne® Original Toothpaste (Brushing Only)
|
12027-027 (1.40% Potassium Oxalate Mouth Rinse)
n=74 Participants
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
|
|---|---|---|---|
|
Mean Tactile Sensitivity VAS Score at Week 4
|
39.49 units on a scale (mm)
Standard Error 1.815
|
30.94 units on a scale (mm)
Standard Error 1.782
|
29.32 units on a scale (mm)
Standard Error 1.799
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Negative Control (Crest Regular Toothpaste)
n=75 Participants
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
|
Positive Control (Sensodyne Toothpaste)
n=76 Participants
Sensodyne® Original Toothpaste (Brushing Only)
|
12027-027 (1.40% Potassium Oxalate Mouth Rinse)
n=74 Participants
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
|
|---|---|---|---|
|
Mean Cold Air Stimulus VAS Score at Week 2
|
43.65 units on a scale (mm)
Standard Error 1.612
|
38.74 units on a scale (mm)
Standard Error 1.600
|
40.22 units on a scale (mm)
Standard Error 1.623
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Negative Control (Crest Regular Toothpaste)
n=73 Participants
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
|
Positive Control (Sensodyne Toothpaste)
n=76 Participants
Sensodyne® Original Toothpaste (Brushing Only)
|
12027-027 (1.40% Potassium Oxalate Mouth Rinse)
n=74 Participants
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
|
|---|---|---|---|
|
Mean Cold Air Stimulus VAS Score at Week 4
|
39.54 units on a scale (mm)
Standard Error 1.792
|
28.36 units on a scale (mm)
Standard Error 1.755
|
29.30 units on a scale (mm)
Standard Error 1.780
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Negative Control (Crest Regular Toothpaste)
n=75 Participants
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
|
Positive Control (Sensodyne Toothpaste)
n=76 Participants
Sensodyne® Original Toothpaste (Brushing Only)
|
12027-027 (1.40% Potassium Oxalate Mouth Rinse)
n=74 Participants
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
|
|---|---|---|---|
|
Global Subjective VAS Score at Week 2
|
44.94 units on a scale (mm)
Standard Error 1.426
|
43.68 units on a scale (mm)
Standard Error 1.416
|
43.64 units on a scale (mm)
Standard Error 1.434
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Negative Control (Crest Regular Toothpaste)
n=73 Participants
Crest® Cavity Protection Regular Toothpaste (Brushing Only)
|
Positive Control (Sensodyne Toothpaste)
n=76 Participants
Sensodyne® Original Toothpaste (Brushing Only)
|
12027-027 (1.40% Potassium Oxalate Mouth Rinse)
n=74 Participants
Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
|
|---|---|---|---|
|
Global Subjective VAS Score at Week 4
|
41.32 units on a scale (mm)
Standard Error 1.664
|
32.79 units on a scale (mm)
Standard Error 1.630
|
35.19 units on a scale (mm)
Standard Error 1.651
|
Adverse Events
Negative Control (Crest Regular Toothpaste)
Positive Control (Sensodyne Toothpaste)
12027-027 (1.40% Potassium Oxalate Mouth Rinse)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael Lynch, DMD, PhD/Study Director
Johnson & Johnson Consumer and Personal Products Worldwide
Results disclosure agreements
- Principal investigator is a sponsor employee Principal investigator agreed not to publish the study results without prior sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER