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Xylitol Disk Use in Adults With Dry Mouth

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University of Washington

关键词

抽象

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.

描述

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.

日期

最后验证: 11/30/2013
首次提交: 03/26/2013
提交的预估入学人数: 03/26/2013
首次发布: 04/03/2013
上次提交的更新: 11/30/2013
最近更新发布: 12/02/2013
实际学习开始日期: 02/28/2013
预计主要完成日期: 07/31/2013
预计完成日期: 07/31/2013

状况或疾病

Mutans Streptococci
Xerostomia

干预/治疗

Other: Xylitol disk

-

手臂组

干预/治疗
Experimental: 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.
Other: Xylitol disk

资格标准

有资格学习的年龄 21 Years 至 21 Years
有资格学习的性别All
接受健康志愿者
标准

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

结果

主要结果指标

1. Mutans streptococci levels [One week]

Change in mutans streptococci levels from Baseline to one week.

2. Mutans streptococci levels [Two weeks]

Change in mutans streptococci levels from Baseline to two weeks.

次要成果指标

1. 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.

2. GRIX measure of xerostomia [Two weeks]

Change in Groningen Radiotherapy-Induced Xerostomia (GRIX) quality of life questionnaire assessing xerostomia symptoms from Baseline to two weeks.

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