A Clinical Study on the Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients in Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Plaque Index, PLI
研究概览
简要总结
The purpose of this study is to treat with traditional Chinese medicine mouthwash, and through the research of dental plaque detection and xerostomia questionnaire and traditional Chinese medicine treatment mechanism.
详细描述
The study will recruit 58 patients who are hospitalized at Lo-Sheng Sanatorium, Ministry of Health and Welfare. Investigators will use xerostomia questionnaire and PLI examination to collect the subject's data. Separate subjects in to two group randomly. The control group will use the traditional Chinese medicine mouthwash, and the other group will use the dilute 50 times of traditional Chinese medicine mouthwash.
Every 7 days will record the PLI value and conduct a xerostomia questionnaire, until 21 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residents of Lo-Sheng sanatorium of the Ministry of Health and Welfare, Taiwan
- •Compliant with the presence of more than four teeth in each of the upper and lower four regions
- •Those who have not used antibiotics and mouthwash two months before the test
排除标准
- •Moderate to severe dementia
- •CDR (Clinical Dementia Assessment Scale) is greater than or equal to 2 points or more
- •Those with a score of less than 17 on the MMSE Simple Mind Scale
- •Nasogastric Tube Inserters
- •Those who are allergic to mouthwash
- •Those who are on course of antibiotics and steroids
- •Those who have had dental cleansing within one month
研究组 & 干预措施
Traditional Chinese Medicine Mouthwash Group
The subjects use traditional Chinese medicine mouthwash after three meals a day and before going to bed, four times a day for 7 consecutive days. After 7 days, record the PLI value and conduct a xerostomia questionnaire, and then retrieve the mouthwash bottle the remaining dose was checked to determine compliance. Those with significantly poor compliance were excluded from the experiment, and then the daily cleaning measures were resumed. The subjects still followed the way of mouthwash four times a day until the end of the 21st day after the xerostomia questionnaire.
干预措施: Traditional Chinese Medicine mouthwash (Other)
Dilute 50 times of Traditional Chinese Medicine Mouthwash Group
The subjects use dilute 50 times traditional Chinese medicine mouthwash after three meals a day and before going to bed, four times a day for 7 consecutive days. After 7 days, record the PLI value and conduct a xerostomia questionnaire, and then retrieve the mouthwash bottle the remaining dose was checked to determine compliance. Those with significantly poor compliance were excluded from the experiment, and then the daily cleaning measures were resumed. The subjects still followed the way of mouthwash four times a day until the end of the 21st day after the xerostomia questionnaire.
干预措施: Dilute 50 times of Traditional Chinese Medicine mouthwash (Other)
结局指标
主要结局
Plaque Index, PLI
时间窗: 21 days
Turesky modification of the Quigley-Hein Plaque Index (TQHPI)
Xerostomia questionnaire
时间窗: 21 days
Xerostomia questionnaire, Pai (2001)
次要结局
未报告次要终点
研究者
Hsu Wei Hung
Director of chinese medicine
Lo-Sheng Sanatorium