Duration of Effect of Biotene Spray in Patients With Dry Mouth

University of Rochester

Status: Completed

Conditions: Dry Mouth

Treatments: Device: Placebo; Device: Biotene

Study type: Interventional

Funder types: Other

Identifiers

NCT03663231

69726

Details and patient eligibility

About

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).

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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37 participants in 2 patient groups, including a placebo group

Biotene

Experimental group

Description:

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

Treatment:

Device: Biotene

Placebo

Placebo Comparator group

Description:

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

Treatment:

Device: Placebo