Trial Outcomes & Findings for Test on a New Experimental Mouth Rinse for Relieving Tooth Sensitivity (NCT NCT02113579)
NCT ID: NCT02113579
Last Updated: 2015-06-10
Results Overview
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. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 4 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score.
COMPLETED
NA
375 participants
4 Weeks
2015-06-10
Participant Flow
Participant milestones
| Measure |
Placebo Control
Placebo Mouth Rinse (10 mL) twice daily after brushing
|
12027-033
Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
|
|---|---|---|
|
Overall Study
STARTED
|
186
|
189
|
|
Overall Study
COMPLETED
|
176
|
185
|
|
Overall Study
NOT COMPLETED
|
10
|
4
|
Reasons for withdrawal
| Measure |
Placebo Control
Placebo Mouth Rinse (10 mL) twice daily after brushing
|
12027-033
Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
6
|
2
|
Baseline Characteristics
Test on a New Experimental Mouth Rinse for Relieving Tooth Sensitivity
Baseline characteristics by cohort
| Measure |
Placebo Control
n=186 Participants
Placebo Mouth Rinse (10 mL) twice daily after brushing
|
12027-033
n=189 Participants
Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
|
Total
n=375 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.9 years
STANDARD_DEVIATION 12.05 • n=93 Participants
|
38.0 years
STANDARD_DEVIATION 12.03 • n=4 Participants
|
38.5 years
STANDARD_DEVIATION 12.03 • n=27 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=93 Participants
|
145 Participants
n=4 Participants
|
283 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
92 Participants
n=27 Participants
|
|
Region of Enrollment
USA
|
186 participants
n=93 Participants
|
189 participants
n=4 Participants
|
375 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 4 WeeksPopulation: Analysis was based on Full Analysis Set, which included all randomized subjects.
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. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 4 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score.
Outcome measures
| Measure |
Placebo Control
n=186 Participants
Placebo Mouth Rinse (10 mL) twice daily after brushing
|
12027-033
n=189 Participants
Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
|
|---|---|---|
|
Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 4
|
44.6 percentage of participants
|
69.3 percentage of participants
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized subjects.
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.
Outcome measures
| Measure |
Placebo Control
n=186 Participants
Placebo Mouth Rinse (10 mL) twice daily after brushing
|
12027-033
n=189 Participants
Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
|
|---|---|---|
|
Mean Cold Air Stimulus VAS Score at Week 4
|
40.04 units on a scale (mm)
Standard Error 1.597
|
25.76 units on a scale (mm)
Standard Error 1.569
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized subjects.
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, at each visit.
Outcome measures
| Measure |
Placebo Control
n=186 Participants
Placebo Mouth Rinse (10 mL) twice daily after brushing
|
12027-033
n=189 Participants
Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
|
|---|---|---|
|
Mean Tactile Sensitivity Score at Week 4
|
15.29 grams
Standard Error 1.315
|
28.74 grams
Standard Error 1.292
|
SECONDARY outcome
Timeframe: 2 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized subjects.
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.
Outcome measures
| Measure |
Placebo Control
n=186 Participants
Placebo Mouth Rinse (10 mL) twice daily after brushing
|
12027-033
n=189 Participants
Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
|
|---|---|---|
|
Mean Cold Air Stimulus VAS Score at Week 2
|
48.04 units on a scale (mm)
Standard Error 1.284
|
40.37 units on a scale (mm)
Standard Error 1.274
|
SECONDARY outcome
Timeframe: 2 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized subjects.
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, at each visit.
Outcome measures
| Measure |
Placebo Control
n=186 Participants
Placebo Mouth Rinse (10 mL) twice daily after brushing
|
12027-033
n=189 Participants
Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
|
|---|---|---|
|
Mean Tactile Sensitivity Score at Week 2
|
12.72 grams
Standard Error 0.692
|
17.42 grams
Standard Error 0.687
|
SECONDARY outcome
Timeframe: 2 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized subjects.
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. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 2 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score.
Outcome measures
| Measure |
Placebo Control
n=186 Participants
Placebo Mouth Rinse (10 mL) twice daily after brushing
|
12027-033
n=189 Participants
Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
|
|---|---|---|
|
Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 2
|
30.6 percentage of participants
|
46.0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized subjects.
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.
Outcome measures
| Measure |
Placebo Control
n=186 Participants
Placebo Mouth Rinse (10 mL) twice daily after brushing
|
12027-033
n=189 Participants
Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
|
|---|---|---|
|
Mean Tactile Sensitivity VAS Score at Week 2
|
44.39 units on a scale (mm)
Standard Error 1.170
|
37.72 units on a scale (mm)
Standard Error 1.161
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized subjects.
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.
Outcome measures
| Measure |
Placebo Control
n=186 Participants
Placebo Mouth Rinse (10 mL) twice daily after brushing
|
12027-033
n=189 Participants
Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
|
|---|---|---|
|
Mean Tactile Sensitivity VAS Score at Week 4
|
38.24 units on a scale (mm)
Standard Error 1.368
|
26.72 units on a scale (mm)
Standard Error 1.345
|
SECONDARY outcome
Timeframe: 2 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized subjects.
At each visit, participants rated their perception of the pain/discomfort experienced 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. 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 elicit your dentinal hypersensitivity pain/discomfort since you have been 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 |
Placebo Control
n=186 Participants
Placebo Mouth Rinse (10 mL) twice daily after brushing
|
12027-033
n=189 Participants
Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
|
|---|---|---|
|
Global Subjective VAS Score at Week 2
|
45.33 units on a scale (mm)
Standard Error 1.009
|
42.09 units on a scale (mm)
Standard Error 1.001
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized subjects.
At each visit, participants rated their perception of the pain/discomfort experienced 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. 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 elicit your dentinal hypersensitivity pain/discomfort since you have been 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 |
Placebo Control
n=186 Participants
Placebo Mouth Rinse (10 mL) twice daily after brushing
|
12027-033
n=189 Participants
Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
|
|---|---|---|
|
Global Subjective VAS Score at Week 4
|
39.00 units on a scale (mm)
Standard Error 1.337
|
31.39 units on a scale (mm)
Standard Error 1.311
|
Adverse Events
Placebo Control
12027-033
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 Investigators agreed not to publish the study results without prior sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER