A Clinical Trial of Tea Catechin Mouth-washing for Removal of Intraoral Bacteria in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Removal of intraoral pathogenic bacteria identified before the study
研究概览
简要总结
The Purpose of this study is to evaluate the effects of catechin mouth-washing on the removal of intraoral bacteria in the elderly
详细描述
Catechins are the major components of tea flavonoids and recent in vitro experimental studies have revealed that tea catechin extracts induce bactericidal effects. However, a limited number of studies have been conducted on the clinical effects of tea catechin against bacterial infection and also the effects in the elderly is unclear. Based on these backgrounds, we designed a prospective randomized controlled study to evaluate the effects of catechin mouth washing on oral pathogenic bacterial detected in the elderly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged over 65 years
- •detected oral pathogenic bacterium and revalidated during the wash-out period
- •without antibacterial medicine, other mouth-washing remedies during the study
- •Obtained written informed consent before participation
排除标准
- •possessing some infectious diseases in need of therapy
- •possessing tea or catechin allergy
- •diagnosed as inadequate for other reasons to participate the study by principal investigator
结局指标
主要结局
Removal of intraoral pathogenic bacteria identified before the study
时间窗: After intervention
次要结局
- Reduction of intraoral bacteria after the study(After intervention)
研究者
Masahiro Morikawa
Clinical trials management office
University of Shizuoka