Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor, Plaque and Papillary Bleeding Indices in Gingivitis Patients.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- level of volatile sulfur compounds in mouth air (part per billion)
研究概览
简要总结
The purpose of this study is to determine effect of Mouthwash containing Camellia sinensis extracts on oral malodor and gingival inflammation in gingivitis subjects.
详细描述
At baseline, level of volatile sulfur compounds (VSC) in mouth air, Plaque Index and Papillary Bleeding Index will be recorded. Gingivitis subjects will be asked to rinse with Camellia sinensis mouthwash or placebo mouthwash. VSC level will be measured at 30 minutes and 3 hours post-rinsing. For the following 4 weeks, subjects will be rinsed with the assigned mouthwash twice daily after toothbrushing. All parameter will be recorded again at Day 28.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 20 teeth
- •clinical diagnosis as plaque induced gingivitis
- •having over 80 ppb of volatile sulfur compounds in mouth air
排除标准
- •denture wearer
- •having systemic diseases or oral pathology
- •taking antibiotics 1 month prior to study
研究组 & 干预措施
Mouthwash A
Mouthwash A: Camellia sinensis mouthwash
干预措施: Camellia sinensis mouthwash (Drug)
Mouthwash B
Mouthwash B: Placebo mouthwash
干预措施: Placebo mouthwash (Drug)
结局指标
主要结局
level of volatile sulfur compounds in mouth air (part per billion)
时间窗: baseline, 30 minutes, 3 hours, 28 days
次要结局
- Papillary bleeding index(baseline, 28 days)