Trial Outcomes & Findings for A Test on a New Experimental Mouth Rinse for Relieving Tooth Sensitivity (NCT NCT01727258)

NCT ID: NCT01727258

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

153 participants

Primary outcome timeframe

4 weeks

Results posted on

2015-06-10

Participant Flow

Participant milestones

Participant milestones
Measure	Colgate Regular Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).	Sensodyne Toothpaste 5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).	Potassium Oxalate Mouthrinse Potassium Oxalate Mouthrinse (experimental group)(12027-033).
Overall Study STARTED	51	51	51
Overall Study COMPLETED	49	48	50
Overall Study NOT COMPLETED	2	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Colgate Regular Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).	Sensodyne Toothpaste 5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).	Potassium Oxalate Mouthrinse Potassium Oxalate Mouthrinse (experimental group)(12027-033).
Overall Study Adverse Event	0	2	0
Overall Study Noncompliance with Study Drug	0	0	1
Overall Study Withdrawal by Subject	1	1	0
Overall Study Lost to Follow-up	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Colgate Regular n=51 Participants Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).	Sensodyne Toothpaste n=51 Participants 5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).	Potassium Oxalate Mouthrinse n=51 Participants Potassium Oxalate Mouthrinse (experimental group)(12027-033).	Total n=153 Participants Total of all reporting groups
Age, Continuous	38.4 years STANDARD_DEVIATION 10.97 • n=93 Participants	37.0 years STANDARD_DEVIATION 11.56 • n=4 Participants	39.9 years STANDARD_DEVIATION 10.46 • n=27 Participants	38.4 years STANDARD_DEVIATION 11.00 • n=483 Participants
Sex: Female, Male Female	33 Participants n=93 Participants	37 Participants n=4 Participants	39 Participants n=27 Participants	109 Participants n=483 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	14 Participants n=4 Participants	12 Participants n=27 Participants	44 Participants n=483 Participants
Region of Enrollment USA	51 participants n=93 Participants	51 participants n=4 Participants	51 participants n=27 Participants	153 participants n=483 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: 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

Outcome measures
Measure	Colgate Regular n=49 Participants Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)	Sensodyne Toothpaste n=48 Participants 5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)	Potassium Oxalate Mouthrinse n=50 Participants Potassium Oxalate Mouthrinse (experimental group)(12027-033)
Mean Tactile Sensitivity Score at Week 4	11.21 grams of force Standard Error 1.221	23.81 grams of force Standard Error 1.234	22.07 grams of force Standard Error 1.210

PRIMARY outcome

Timeframe: 2 weeks

Population: 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

Outcome measures
Measure	Colgate Regular n=50 Participants Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)	Sensodyne Toothpaste n=49 Participants 5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)	Potassium Oxalate Mouthrinse n=50 Participants Potassium Oxalate Mouthrinse (experimental group)(12027-033)
Mean Tactile Sensitivity Score at Week 2	11.09 grams of force Standard Error 0.832	17.00 grams of force Standard Error 0.840	17.18 grams of force Standard Error 0.832

SECONDARY outcome

Timeframe: 2 weeks

Population: 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 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

Outcome measures
Measure	Colgate Regular n=50 Participants Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)	Sensodyne Toothpaste n=49 Participants 5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)	Potassium Oxalate Mouthrinse n=50 Participants Potassium Oxalate Mouthrinse (experimental group)(12027-033)
Mean Tactile Sensitivity VAS Score at Week 2	43.80 units on a scale (mm) Standard Error 2.009	36.95 units on a scale (mm) Standard Error 2.020	37.08 units on a scale (mm) Standard Error 2.017

SECONDARY outcome

Timeframe: 4 weeks

Population: 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 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

Outcome measures
Measure	Colgate Regular n=49 Participants Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)	Sensodyne Toothpaste n=48 Participants 5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)	Potassium Oxalate Mouthrinse n=50 Participants Potassium Oxalate Mouthrinse (experimental group)(12027-033)
Mean Tactile Sensitivity VAS Score at Week 4	38.38 units on a scale (mm) Standard Error 2.342	26.40 units on a scale (mm) Standard Error 2.353	31.45 units on a scale (mm) Standard Error 2.327

SECONDARY outcome

Timeframe: 2 weeks

Population: 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 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

Outcome measures
Measure	Colgate Regular n=50 Participants Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)	Sensodyne Toothpaste n=49 Participants 5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)	Potassium Oxalate Mouthrinse n=50 Participants Potassium Oxalate Mouthrinse (experimental group)(12027-033)
Mean Cold Air Stimulus VAS Score at Week 2	45.41 units on a scale (mm) Standard Error 2.233	32.89 units on a scale (mm) Standard Error 2.246	37.15 units on a scale (mm) Standard Error 2.227

SECONDARY outcome

Timeframe: 4 weeks

Population: 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 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

Outcome measures
Measure	Colgate Regular n=49 Participants Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)	Sensodyne Toothpaste n=48 Participants 5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)	Potassium Oxalate Mouthrinse n=50 Participants Potassium Oxalate Mouthrinse (experimental group)(12027-033)
Mean Cold Air Stimulus VAS Score at Week 4	42.03 units on a scale (mm) Standard Error 2.511	24.56 units on a scale (mm) Standard Error 2.524	30.10 units on a scale (mm) Standard Error 2.479

Adverse Events

Colgate Regular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sensodyne Toothpaste

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Potassium Oxalate Mouthrinse

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Phone: 908-433-6423 USA EST

Email: [email protected]

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