Xylitol Disk Use in Adults With Dry Mouth

Xerostomia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823445
• Other study ID #: XM2013
• Status: Completed
• Phase: N/A
• First received: March 27, 2013
• Last updated: December 1, 2013
• Start date: March 2013
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mutans Streptococci
• Xerostomia

Intervention

Other:
• Xylitol disk

Locations

Country	Name	City	State
United States	University of Washington, School of Dentistry, Regional Clinical Dental Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mutans streptococci levels	Change in mutans streptococci levels from Baseline to one week.	One week	No
Primary	Mutans streptococci levels	Change in mutans streptococci levels from Baseline to two weeks.	Two weeks	No
Secondary	GRIX measure of xerostomia	Change in Groningen Radiotherapy-Induced Xerostomia (GRIX) quality of life questionnaire assessing xerostomia symptoms from Baseline to one week.	One week	No
Secondary	GRIX measure of xerostomia	Change in Groningen Radiotherapy-Induced Xerostomia (GRIX) quality of life questionnaire assessing xerostomia symptoms from Baseline to two weeks.	Two weeks	No