Tooth Sensitivity Relief by Two Mouthrinses

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 6 visits over 8 weeks. During the first 2 weeks, everyone will just brush their teeth two times a day with the fluoride toothpaste provided. Then you will be assigned to a mouthwash group if you qualify to continue in the study. Two groups will get mouthwash with a certain amount of an experimental ingredient and one group will get a mouthwash with no experimental ingredients. You will have an equal chance of being assigned to any one of the three groups. For the next 6 weeks, you will rinse with your assigned mouthwash after brushing. 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 a double-blind, randomized, parallel group, single center, controlled clinical trial design. Approximately 200 generally healthy adults meeting the necessary inclusion/exclusion criteria will be enrolled so that 180 subjects (60 per treatment 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), Week 1, Week 2, Week 4 & Week 6. 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 standard fluoride toothpaste. Subjects will be instructed to rinse twice daily, after brushing, with the provided mouthrinse for 60 seconds using 10 ml or 20 ml (depending on the treatment group), for 6 consecutive weeks.

Official Title
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Evaluation of the Efficacy of Two Potassium Oxalate Containing Mouthrinses for Relieving Dentinal Hypersensitivity

Conditions
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Dentin Sensitivity

Intervention / Treatment
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* Device: 12027-019
* Device: 12027-020
* Device: 12027-021


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. A minimum of 2 natural premolars, canines, and/or incisors teeth with decay-free scorable facial/buccal surfaces which must present cervical abrasion, and/or erosion and/or gingival recession. A minimum of two eligible teeth (premolars, canines and/or incisors) with a Screening (-2 weeks Baseline) and Baseline tactile sensitivity score between 10 - 50 grams after application of the Yeaple probe and a cold air stimulus VAS score of 30 - 80 mm on a 100 mm VAS scale will be followed as study teeth during the trial. No more than two eligible teeth per quadrant each separated by 2 other teeth must be selected.Absence of significant oral soft tissue pathology, based on the dentist's visual examination and at the discretion of the investigator. Adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of oral neglect). Absence of severe marginal gingivitis, moderate/advanced periodontitis (ADA Type III, IV) based on a clinical examination and discretion of the Investigator. Absence of extensive supragingival calculus. Exclusion Criteria: Volunteers who report history or presence of kidney disorders, kidney stones, eating disorders, uncontrolled GERD, excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity. Volunteers with chronic medical debilitating disease associated with constant or intermittent episodes of daily pain. Long-term daily use (≥ 7 consecutive days) of analgesics and any other drugs that at the discretion of the Investigator would compromise the response of the hypersensitivity assessments. Volunteers who have been using any home-care bleaching, whitening products or have had a professional bleaching treatment within 4 weeks of the Screening visit. Use of desensitizing agents whether prescribed or over-the-counter within eight weeks prior to screening visit (any sensitivity toothpastes such as Crest Sensitivity, Sensodyne, Crest Pro-Health, Colgate Sensitivity Relief, any mouthwash and oral care products used for the treatment of dentinal hypersensitivity). Volunteers who during the study will receive dental treatment which may affect their dentinal hypersensitivity condition (i.e. oral prophylaxis). Emergency treatment will be allowed. Those requiring antibiotic premedication prior to invasive dental procedures. Participation in a dental clinical trial involving oral care products within the past 30 days. Women who are pregnant, nursing or plan to become pregnant during the course of the study. Teeth that are grossly carious, orthodontically banded, abutment teeth for fixed or removable prostheses, crowned teeth, or third molars will not be included in the study. Periodontal surgery and orthodontic treatment within previous 3 months. Extensive restorative treatment (i.e. extensively restored teeth or teeth with restoration(s) extending into the test area) at the discretion of the Investigator. Dental prophylaxis within 2 weeks prior to Screening visit. Teeth or periodontium with pathology or defect likely to cause pain. Teeth with clinical mobility > grade 1.

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: PO-019<br>1.40% Potassium Oxalate Sensitive Mouthwash without fluoride (12027-019) | Device: 12027-019<br>* Rinse with 10 mL for 60 seconds twice daily after brushing in your usual manner for 1 minute using at least a one-inch strip of the assigned toothpaste.<br>* Other names: 1.40% Potassium Oxalate Sensitive Mouthwash without fluoride;|
| Experimental: PO-020<br>1.40% Potassium Oxalate Sensitive Mouthwash with fluoride (12027-020) | Device: 12027-020<br>* Rinse with 20 mL for 60 seconds twice daily after brushing in your usual manner for 1 minute using at least a one-inch strip of the assigned toothpaste.<br>* Other names: 1.40% Potassium Oxalate Sensitive Mouthwash with fluoride;|
| Sham Comparator: PO-021<br>Vehicle Control Mouthrinse (without potassium oxalate and without fluoride) (12027-021) | Device: 12027-021<br>* Rinse with 10 mL for 60 seconds twice daily after brushing in your usual manner for 1 minute using at least a one-inch strip of the assigned toothpaste<br>* Other names: Vehicle Control Mouthrinse;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Tactile Sensitivity Score at Week 6 | 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. | 6 Weeks | 
| 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, at each visit. | 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, at each visit. | 2 Weeks | 
| Mean Tactile Sensitivity Score at Week 1 | 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. | 1 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Tactile Sensitivity VAS Score at Week 1 | 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. | 1 Week | 
| Mean Tactile Sensitivity VAS Score at Week 2 | 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. | 2 Weeks | 
| Mean Tactile Sensitivity VAS Score at Week 4 | 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. | 4 Weeks | 
| Mean Tactile Sensitivity VAS Score at Week 6 | 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. | 6 Weeks | 
| Mean Cold Air Stimulus VAS Score at Week 1 | 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. | 1 Week | 
| 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 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. | 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 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. | 4 Weeks | 
| Mean Cold Air Stimulus VAS Score at Week 6 | 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. | 6 Weeks | 
| Global Subjective VAS Score at Week 1 | At Week 1, 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 week 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. | 1 Week | 
| Global Subjective VAS Score at Week 2 | At Week 2, 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 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 Week 4, 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 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 | 
| Global Subjective VAS Score at Week 6 | At Week 6, 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 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. | 6 Weeks |