Duration of Effect of Biotene Spray in Patients With Dry Mouth

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-11

Study Completion Date

2019-11-22

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).

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Detailed Description

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Conditions

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Dry Mouth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Biotene

People who present with dry mouth and will receive a single dose of Biotene.

Group Type EXPERIMENTAL

Biotene

Intervention Type DEVICE

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.

Placebo

People who present with dry mouth and will receive a single dose of an alternative agent.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

IND/IDE exempt device primarily water

Interventions

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Biotene

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.

Intervention Type DEVICE

Placebo

IND/IDE exempt device primarily water

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No