NCT01113528已完成2 期
The Effect of Host Response Modulation Therapy (Omega 3 Plus Low-dose Aspirin) as an Adjunctive Treatment of Chronic Periodontitis (Clinical and Biochemical Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cytokine levels
研究概览
简要总结
To evaluate the efficacy of systemic administration of omega 3 PUFA plus low dose aspirin as an adjunctive therapy to regenerative modality of grade II furcation defects in periodontitis patients.
详细描述
In this study, we tested the hypothesis that the administration of omega 3 PUFA plus low dose aspirin would augment the results following regenerative therapy of furcation defects in chronic periodontitis patients.
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
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •suffering moderate to sever chronic periodontitis and displaying at least a single grade II furcation defect according to Glickman's classification 1953, determined by both clinical and radiographic examinations;
- •free from systemic diseases known to influence the periodontal condition and not receiving any medication known to affect the periodontal status;
- •have not receive any periodontal therapy for a minimum of 6 months prior to the study.
排除标准
- •Known hypersensitivity or allergy to one of the used medications
- •Pregnancy or lactation
- •Heavy smoking (more than 10cigarretes/day)
- •History of alcohol abuse
- •Participation in other clinical trials
研究组 & 干预措施
Regenerative therapy
Experimental
干预措施: Regenerative therapy (omega 3 PUFA plus low dose aspirin) (Other)
Sugar pill
Placebo Comparator
干预措施: Sugar pill (Drug)
结局指标
主要结局
Cytokine levels
时间窗: six months
Interleukin-1 beta Interleukin-10
次要结局
- Gingival inflammation(six months)
- Healing after regenerative therapy(six months)
研究者
研究点 (1)
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