Effects of a Night Guard on Aphthous Stomatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- number of developed aphthous stomatitis
研究概览
简要总结
The investigators will investigate whether the night guard can suppress the development of recurrent aphthous stomatitis (RAS). The investigators will record the patients' oral condition for 60 days before and after intervention with the night guard made of Ethylene-Vinyl Acetate copolymer (EVA). The patients' saliva will be analyzed for measurement of inflammatory cytokines or oxidative stress.
详细描述
The study involved 20 patients (8 male and 12 female) with RAS. These patients suffered from RAS at least once a month. The investigators will record their oral condition for 60 days before and after intervention with the night guard made of EVA. Their saliva will be analyzed for further studies including measurement of inflammatory cytokines or oxidative stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients suffered from recurrent aphthous stomatitis at least once a month
排除标准
- •People do not have a experience of recurrent aphthous stomatitis
研究组 & 干预措施
Night guard
the night guard made of EVA
干预措施: night guard (Device)
Placebo night guard
Placebo night guard made of EVA
干预措施: placebo night guard (Device)
结局指标
主要结局
number of developed aphthous stomatitis
时间窗: through study completion, an average of 1 year
次要结局
- days until healing(through study completion, an average of 1 year)
研究者
Yasusei Kudo
Associate Professor
University of Tokushima