NCT00918060Unknown2 期
Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 48
- 主要终点
- pocket depth reduction, clinical attachment level gain, gingival index, bleeding score
研究概览
简要总结
The purpose of this study is to evaluate clinical result including plaque index, gingival inflammation, bleeding score, pocket depth reduction and clinical attachment level gain after used locally-delivered gel containing Camella sinensis extracts as an adjunctive treatment in periodontal therapy
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 34 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects have sound tooth with pocket depth = or > 5 mm. without caries, restoration, mobility and furcation involvement
- •no systemic complicated factors
- •no allergy to green tea or product of green tea
- •signing in informed consent form
排除标准
- •pregnancy or lactation
- •antibiotic premedication or antibiotic intake in previous 3 month
研究组 & 干预措施
gel a
Experimental
干预措施: Camella sinensis gel (Drug)
gel b
Placebo Comparator
干预措施: Camella sinensis gel (Drug)
结局指标
主要结局
pocket depth reduction, clinical attachment level gain, gingival index, bleeding score
时间窗: baseline, 1, 3 and 6 month after gel had loaded
次要结局
- plaque index(baseline, 1, 3, and 6 month after gel had loaded)
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