A Pilot Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse

Study Overview
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Brief Summary
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The objective of this pilot study is to determine if an experimental mouth rinse and a marketed dry mouth rinse are more effective in relieving dry mouth compared to water.

Detailed Description
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This is a controlled, randomized, 3-treatment, 3-period crossover study in subjects with self-reported dry mouth symptoms as determined by subject responses (as determined by the response to relieving the discomfort of dry mouth question from the modified Product Performance and Attributes Questionnaire I/ Moisturization and Dryness (PPAQ I/ MD)) compared to water. Subjects enrollment is based on the responses to the Dry Mouth Inventory (DMI). A sufficient number of volunteers will be screened to ensure enrollment of up to 30 subjects at Acclimation. Subjects who meet the eligibility criteria will continue into the treatment phase of the study. Safety will be assessed by Oral examinations at Baseline/Day1 and Day 4. Subjects will complete questionnaires at Baseline (before product use Day 1 only), after immediate use, 30 minutes, 1 hour, 2 hours, and 4 hours after supervised product use on Day 1 and Day 4 of each period. The PPAQ II questionnaire will be completed in the morning of Day 4 of each period. Subjects will be randomly assigned to treatment sequences at the Baseline visit of Period 1. The treatment and washout periods will be repeated until all three treatment periods have been completed.

Official Title
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A Pilot Clinical Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse Compared to a Negative Control

Conditions
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Dry Mouth

Intervention / Treatment
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* Device: Marketed Dry Mouth Rinse
* Other: Water control
* Device: Experimental Dry Mouth Rinse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent prior to participation and be given a signed copy of the informed consent form; Be at least 18 years of age; Be in good general health as determined by the Investigator/designee; Agree not to participate in any other oral care studies for the duration of this study; Agree to delay elective dentistry, including dental prophylaxis, until study completion, and to report any non-study dentistry received during the course of the study; Agree to refrain from the use of any non-study oral hygiene products for the study duration including mouth rinse and toothpaste (flossing is permitted if part of their normal routine); Self-report a dry mouth feeling according to the modified DMI questions. (Subject must answer at least 2 out of 4 questions with 'agree a little,' 'agree' or 'strongly agree'); Agree to refrain from smoking, drinking, using tobacco products, using breath mints, medicated lozenges, or chewing gum during the 4-hour test period; Agree to return for all scheduled visits and to follow all study procedures. Exclusion Criteria: Any condition or disease, as determined by the Investigator/Designee, that could be expected to interfere with examination procedures, with compliance, or with the subject's safe completion of the study; Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession; Active treatment for periodontitis; Having a history of allergies or hypersensitivity to mouth rinse or ingredients in commercial dental products or cosmetics; Self-reported pregnancy or the intent to become pregnant during the study, or breast feeding; Full or partial dentures or any orthodontic appliances such as braces or aligners, or tongue or mouth piercing; Having diabetes; Inability to undergo any study procedure; Having untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g., current oral ulceration); Use of prescription systemic parasympathetic medications (e.g., Pilocarpine), for the treatment of the feeling of dry mouth; Currently under the care of a dental/medical professional specifically for the treatment of dry mouth (at the discretion of the Investigator/Designee); Self-reported mouth breathers (i.e., mouth breathing secondary to nasal obstruction); Evidence of gross intra-oral neglect or need for extensive dental therapy; or Currently undergoing radiotherapy and/or chemotherapy treatment.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 3-treatment crossover, with 4 days of use
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Marketed Mouth Rinse<br>dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4. | Device: Marketed Dry Mouth Rinse<br>* relieves dry mouth symptoms by physically coating oral mucosal surfaces.<br>|
| Experimental: Experimental Mouth Rinse<br>dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4. | Device: Experimental Dry Mouth Rinse<br>* relieves dry mouth symptoms by physically coating oral mucosal surfaces.<br>|
| Sham Comparator: Water/Negative Control<br>subjects will swallow 15 ml of water (on-site). Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after water intake (on-site) on Day 1 and Day 4. | Other: Water control<br>* negative control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product Performance and Attributes (PPAQ I) Question #1: 2-hr at Day 4 | Product Performance and Attributes (PPAQ I) Question #1: Since you have been used the product, please rate each of the following at this timepoint: (Select one response for each attribute)- excellent=5, very good=4, good=3, fair=2, poor=1: 1) Relieves the discomfort of your dry mouth | 2-hour, Day 4 |