Duration of Effect of Biotene Spray in Patients With Dry Mouth

Study Overview
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Brief Summary
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To determine the duration of effect of a single dose of Biotène Moisturizing Mouth Spray in subjects who complain of a clinically dry mouth. The effect of the product will be compared to a control spray (water).

Official Title
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Duration of Effect of Biotene Spray in Patients With Symptomatic Dry Mouth

Conditions
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Dry Mouth

Intervention / Treatment
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* Device: Biotene
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults who are in good general health and reply initially affirmatively to the question, Do you feel that your mouth is too dry and causes you discomfort at times during the day other than on awakening from sleep? This question is an adaptation of the question used successfully by Jose and others (2016) to recruit study subjects. Adults who are able to communicate easily in English and who are able to demonstrate understanding of the study instructions. Adults who are physically able to perform an unstimulated whole saliva flow rate (UWSFR) test and who produce 0.2 mL/min or less of saliva. Exclusion Criteria: Adults under the care of a health professional specifically for xerostomia treatment, including those taking prescription systemic parasympathetic medications. Adults who regularly self-medicate their xerostomia with water or other agents or products designed to treat their xerostomia and are unwilling or unable to cease use of the agent for at least 48 hours prior to the two test visits. Adults who are primarily mouth breathers (i.e. mouth breathing secondary to nasal obstruction) Adults who cannot consent for themselves or have physical/mental disabilities requiring a caregiver. Adults with a known allergy to any of the ingredients in Biotène Spray (eg. dairy allergy)

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biotene<br>People who present with dry mouth and will receive a single dose of Biotene. | Device: Biotene<br>* Biotène Dry Mouth Moisturizing Spray contains water, polyglycitol, propylene glycol, sunflower oil, xylitol, milk protein extract, potassium sorbate, acesulfame K, potassium thiocyanate, lysozyme, lactoferrin, lactoperoxidase. 3 sprays, approximately 15 mL.<br>|
| Placebo Comparator: Placebo<br>People who present with dry mouth and will receive a single dose of an alternative agent. | Device: Placebo<br>* IND/IDE exempt device primarily water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Duration of Action of Intervention | Participant will receive a dose of Biotene or placebo (water) and will be asked if their mouth is dry up to 2 hrs. The time at which their mouth becomes dry again will be the duration of action. | baseline up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Tolerability of Product | Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: The taste of the product was tolerable. | 2 hours | 
| Mean Acceptability of Product | Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: The thickness of the product was acceptable. | 2 hours | 
| Mean Continued Use of Project | Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: I would like to continue using this product. | 2 hours | 
| Mean Purchase Product Rating | Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: I would purchase this product to use on a regular basis. | 2 hours | 
| Mean Ease of Use of Product | Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: This product is easy to use. | 2 hours | 
| Mean Preference for Another Product | Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: I would prefer using another product. | 2 hours |