N/A
N=29
Duration of Effect of Biotene Spray in Patients With Dry Mouth
Dry Mouth
Bottom Line
View on ClinicalTrials.gov: NCT03663231 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Mean Duration of Action of Intervention — 27; 26 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biotene (Device); Placebo (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Duration of Action of Intervention |
27; 26 | — |
| SECONDARY Mean Tolerability of Product |
4.2; 3.8 | — |
| SECONDARY Mean Acceptability of Product |
4.2; 3.9 | — |
| SECONDARY Mean Continued Use of Project |
3.1; 2.9 | — |
| SECONDARY Mean Purchase Product Rating |
2.9; 2.6 | — |
| SECONDARY Mean Ease of Use of Product |
4.0; 3.9 | — |
| SECONDARY Mean Preference for Another Product |
3.2; 3.4 | — |
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).
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03663231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.