Xylitol Disk Use in Adults With Dry Mouth

XyliMelts Ability to Reduce Mutans Streptococci in Adults With the Perception of Dry Mouth

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01823445

Enrollment

Registered

2013-04-04

Start date

2013-03-31

Completion date

2013-08-31

Last updated

2013-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mutans Streptococci, Xerostomia

Keywords

Xylitol, Dental caries

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.

Interventions

OTHERXylitol disk

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Mutans streptococci levels	One week	Change in mutans streptococci levels from Baseline to one week.

Secondary

Measure	Time frame	Description
GRIX measure of xerostomia	One week	Change in Groningen Radiotherapy-Induced Xerostomia (GRIX) quality of life questionnaire assessing xerostomia symptoms from Baseline to one week.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026