Duration of Effect of Biotene Spray in Patients With Dry Mouth (NCT03663231) | Clinical Trial Compass
CompletedNot Applicable
Duration of Effect of Biotene Spray in Patients With Dry Mouth
United States37 participantsStarted 2019-02-11
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)