Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xylitol disk | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xylitol disk | Other |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mutans streptococci levels | Change in mutans streptococci levels from Baseline to one week. | One week |
| Mutans streptococci levels | Change in mutans streptococci levels from Baseline to two weeks. | Two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| GRIX measure of xerostomia |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Milgrom, DDS | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington, School of Dentistry, Regional Clinical Dental Research Center | Seattle | Washington | 98195 | United States |
Not provided
| ID | Term |
|---|---|
| D014987 | Xerostomia |
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D017001 | Tooth Demineralization |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Change in Groningen Radiotherapy-Induced Xerostomia (GRIX) quality of life questionnaire assessing xerostomia symptoms from Baseline to two weeks.
| Two weeks |
| D014076 |
| Tooth Diseases |