Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Xylitol disk

Other
Who is being recruted

Stomatognathic Diseases+4

+ Mouth Diseases

+ Salivary Gland Diseases

Over 21 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorUniversity of Washington
Last updated: December 3, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Washington
Last updated: December 3, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

7 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Stomatognathic DiseasesMouth DiseasesSalivary Gland DiseasesTooth DiseasesTooth DemineralizationDental CariesXerostomia

Criteria

3 inclusion criteria required to participate
Adults 21 years old or older

Current report of dry mouth

Daily use of at least 2 prescription medications known to cause dry mouth

6 exclusion criteria prevent from participating
Antibiotic use in the last month

Change in medication or dose within the last month

History of gastrointestinal disease

Topical oral antimicrobial (e.g. Chlorhexidine rinse) use in the last month

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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

Seattle, United StatesOpen University of Washington, School of Dentistry, Regional Clinical Dental Research Center in Google Maps
CompletedOne Study Center