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Xylitol Disk Use in Adults With Dry Mouth

NCT ID: NCT01823445

Last Updated: 2013-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-08-31

Brief Summary

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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

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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.

Conditions

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Mutans Streptococci Xerostomia

Keywords

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Xylitol Dental caries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Xylitol disk

Daily use of 8 disks containing 0.5 grams xylitol each for two weeks. The disks adhere to gum tissue with a food grade adhesive backing and slowly dissolve. The disks are applied one on each side of the mouth in the morning after breakfast, again at midday, and four are applied, two on each side, at bedtime.

Group Type EXPERIMENTAL

Xylitol disk

Intervention Type OTHER

Interventions

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Xylitol disk

Intervention Type OTHER

Other Intervention Names

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XyliMelts

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Peter Milgrom

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Milgrom, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington, School of Dentistry, Regional Clinical Dental Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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XM2013

Identifier Type: -

Identifier Source: org_study_id