XyliMelts Ability to Reduce Mutans Streptococci in Adults With the Perception of Dry Mouth
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Mutans streptococci levels
Study Overview
Brief Summary
The purpose of this study is to demonstrate whether decay causing bacteria are reduced when adhesive xylitol disks are used intraorally three times a day for two weeks in adults with dry mouth.
Detailed Description
Xylitol,an FDA approved sugar substitute, has been shown to reduce tooth decay. Patients who experience dry mouth may be more susceptible to dental decay because they lack the protection provided by an adequate flow of saliva. These patients are likely to have high levels of the decay causing bacteria, mutans streptococci.
The purpose of this research is to test the ability of a novel xylitol delivery vehicle to reduce mutans streptococci in patients with dry mouth over a two week period. The delivery vehicle is a slowly dissolving xylitol disk (lozenge) that adheres to soft tissues inside the mouth. Participants will place disks on both sides of the mouth three times a day.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adults 21 years old or older
- •Daily use of at least 2 prescription medications known to cause dry mouth
- •Current report of dry mouth
Exclusion Criteria
- •Antibiotic use in the last month
- •Topical oral antimicrobial (e.g. Chlorhexidine rinse) use in the last month
- •Change in medication or dose within the last month
- •Use of mouthwash within the last week
- •Use of lozenges or chewing gum with 500 mg or more of xylitol on a habitual basis
- •History of gastrointestinal disease
Outcomes
Primary Outcomes
Mutans streptococci levels
Time Frame: Two weeks
Change in mutans streptococci levels from Baseline to two weeks.
Secondary Outcomes
- GRIX measure of xerostomia(Two weeks)
Investigators
Peter Milgrom
Professor
University of Washington