XyliMelts Ability to Reduce Mutans Streptococci in Adults With the Perception of Dry Mouth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Mutans streptococci levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 21 years old or older
- •Daily use of at least 2 prescription medications known to cause dry mouth
- •Current report of dry mouth
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Xylitol disk (Other)
结局指标
主要结局
Mutans streptococci levels
时间窗: Two weeks
Change in mutans streptococci levels from Baseline to two weeks.
Mutans streptococci levels
时间窗: One week
Change in mutans streptococci levels from Baseline to one week.
次要结局
- GRIX measure of xerostomia(Two weeks)
- GRIX measure of xerostomia(One week)
研究者
Peter Milgrom
Professor
University of Washington