Placebo-Control, Randomized, Double Blind Long Term Trial to Evaluate the Efficacy of Garlic Product on Periodontitis
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Prevention of Gindivitis
研究概览
简要总结
This is a randomized, controlled, examiner-blind, 2-treatment parallel group study. The study will be conducted at the Hebrew University, Hadassah, Israel. A sufficient number of subjects will be screened to obtain approximately 200 generally healthy adult volunteers with mild to moderate periodontitis.
Subjects will be stratified and randomly assigned equally to either the regimen group (AGE) or a control group (Placebo).
Subjects will be requested to use the products at home for the duration of the study according to the written and verbal usage instructions given to them during product distribution. At Baseline, Month 6, 12, and 18 subjects will receive oral soft tissue exams, and will have gingival inflammation, bleeding, and periodontal measurements made as described in below.
Both groups will receive supragingival dental prophylaxes every 6 month consistent with local norms and standards. Products will be re-supplied approximately every six months following Baseline. During study conduct, subjects with evidence of progressive periodontal disease (≥3 mm increases in pocket depth, attachment loss or recession) will be exited from the study and treated following local norms.
详细描述
Study Objective The objective of this study is to assess the long-term efficacy of "AGE among on periodontitis for a period of 2 years.
Overall Study Design and Plan This is a randomized, controlled, examiner-blind, 2-treatment parallel group study. The study will be conducted at the Hebrew University, Hadassah, Israel. A sufficient number of subjects will be screened to obtain approximately 200 generally healthy adult volunteers with mild to moderate periodontitis.
Subjects will be stratified and randomly assigned equally to either the regimen group (AGE) or a control group (Placebo).
Subjects will be requested to use the products at home for the duration of the study according to the written and verbal usage instructions given to them during product distribution. At Baseline, Month 6, 12, and 18 subjects will receive oral soft tissue exams, and will have gingival inflammation, bleeding, and periodontal measurements made as described in below.
Both groups will receive supragingival dental prophylaxes every 6 month consistent with local norms and standards. Products will be re-supplied approximately every six months following Baseline. During study conduct, subjects with evidence of progressive periodontal disease will be exited from the study and treated following local norms.
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
- Double (Participant, Investigator)
盲法说明
both, the participants and the investigators will be blind 2 groups will be assigned randomally
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
placebo groupe
Microcrystalline Cellulose 258.55 mg Carboxymethylcellulose Calcium 6 mg Agar Powder 35 mg Coloring Agent 0.45 mg Details: Gardenia Extractive 44.5%, Corn Syrup 55% Potassium pyrophosphate 0.5% Silicon Dioxide 3.5 mg Calcium Stearate 3.5 mg Total Weight 307 mg
干预措施: Aged Garlic Extract (Dietary Supplement)
garlic groupe
Concentrated Aged Garlic Extract Microcrystalline Cellulose 133 mg Carboxymethylcellulose Calcium 6 mg Agar Powder 35 mg Silicon Dioxide 3.5 mg Calcium Stearate 3.5 mg Total Weight 307 mg
干预措施: Aged Garlic Extract (Dietary Supplement)
结局指标
主要结局
Prevention of Gindivitis
时间窗: 4 months
A reduction of bleeding index in the Garlic group
次要结局
未报告次要终点