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

Study Overview
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Brief Summary
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This study is for people with sensitive teeth and involves going to the dentist for 4 visits over 6 weeks. During the first 2 weeks, you will just brush your teeth two times a day with the fluoride toothpaste provided. Then you will be assigned to a group if you qualify to continue in the study. All groups will get a marketed toothpaste and one group will also get a mouthwash with an experimental ingredient. You will have an equal chance of being assigned to any one of the three groups. For the next 4 weeks, you will brush with your assigned toothpaste and rinse with your assigned mouthwash if assigned to the mouthwash group. A dentist will look at your mouth, teeth, tongue and gums and check for sensitive teeth. The investigators will see if the mouthwash helps to reduce tooth sensitivity during the study.

Detailed Description
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This is an observer-blind, randomized, parallel-group, single-center, controlled clinical trial. Approximately 246 generally healthy adults meeting the necessary inclusion/exclusion criteria will be enrolled so that 210 subjects (70 per group) would reasonably be expected to complete the study. Subjects will have their oral soft/hard tissues assessed and will be evaluated for sensitivity levels at Screening (Visit 1), Baseline (Visit 2), Visit 3 at Week 2 and Visit 4 at Week 4. During the first two weeks of the study, subjects will be instructed to brush their teeth for one minute in their usual manner, twice daily, using the provided standard fluoride toothpaste. Subjects will return for the Baseline exam and, upon qualification with entry criteria, will be assigned to one of three treatment groups. Qualified subjects will be instructed to brush their teeth two times daily for one minute in their usual manner using the provided toothpaste (standard fluoride toothpaste or 5% potassium nitrate toothpaste). Subjects assigned to the mouthrinse group will be instructed to rinse twice daily, after brushing, with the provided mouthrinse for 60 seconds using 10 ml, for 4 consecutive weeks.

Official Title
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Assessment of a Potassium Oxalate-Containing Formulation for the Relief of Dentinal Hypersensitivity

Conditions
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Dentin Sensitivity

Intervention / Treatment
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* Device: Mouthwash
* Drug: Potassium nitrate toothpaste
* Drug: Sodium fluoride toothpaste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females at least 18 years of age in good general and oral health without any known allergy to commercial dental products or cosmetics. Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial. Willingness to use the assigned products according to instructions, availability for appointments, and likelihood of completing the clinical trial. The appropriate number and location of eligible teeth, based on protocol-defined standards. Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect). Exclusion Criteria: Any medical or dental history or condition, or use of any medication or drug, that per protocol or in the opinion of the investigator might compromise subject comfort or safety, or the analysis of study results. Volunteers who have been using any of the following within protocol-defined timeframes: home-care bleaching, whitening products or professional bleaching treatment desensitizing agents whether prescribed or over-the-counter sensitivity toothpastes, mouthwash or oral care products used for the treatment of dentinal hypersensitivity Women who are pregnant, nursing or plan to become pregnant during the course of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12027-027<br>Rinse with 10 ml of the assigned mouthwash for 60 seconds after you brush in your usual manner twice daily for one minute using at least a one-inch strip of the assigned toothpaste | Device: Mouthwash<br>* Rinse with 10 ml of the assigned mouthwash for 60 seconds after you brush in your usual manner twice daily for one minute using at least a one-inch strip of the assigned toothpaste<br>* Other names: 1.40% potassium oxalate sensitive mouthwash;|
| Active Comparator: 310158077046<br>Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste | Drug: Potassium nitrate toothpaste<br>* Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste<br>* Other names: Sensodyne Original;|
| Placebo Comparator: 037000003212<br>Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste | Drug: Sodium fluoride toothpaste<br>* Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste<br>* Other names: Crest Cavity Protection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Tactile Sensitivity Score at Week 4 | 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. | 4 weeks | 
| Mean Tactile Sensitivity Score at Week 2 | 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. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Tactile Sensitivity Visual Analog Scale (VAS) Score at Week 2 | 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. | 2 weeks | 
| Mean Tactile Sensitivity VAS Score at Week 4 | 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. | 4 weeks | 
| Mean Cold Air Stimulus VAS Score at Week 2 | 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. | 2 weeks | 
| Mean Cold Air Stimulus VAS Score at Week 4 | 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. | 4 weeks | 
| Global Subjective VAS Score at Week 2 | 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. | 2 weeks | 
| Global Subjective VAS Score at Week 4 | 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. | 4 weeks |