NCT00632957已完成不适用
Center for the Biologic Basis of Oral/Systemic Diseases Project 5: Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- clinical attachment loss
研究概览
简要总结
The purpose of this study is to test the hypothesis that dietary n-3 PUFA will have a beneficial effect on systemic and local markers of inflammation when combined with traditional, non-surgical 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, Investigator, Outcomes Assessor)
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
- •≥ 18 years of age, male or female
- •At least 20 natural teeth present at the time of periodontal examination
- •Be diagnosed with severe, chronic periodontitis;
- •Be willing to participate in the study
排除标准
- •<18 years of age
- •Less than 20 natural teeth present at time of periodontal examination
- •Unable or unwilling to provide informed consent or follow study protocol
- •Systemic conditions including diabetes mellitus and any cardiovascular condition that would require premedication prior to dental treatment
- •Use of systemic antibiotics within the last 3 months
- •Pregnancy as diagnosed by administered pregnancy test.
- •You are nursing a baby.
- •Are allergic to fish or fish products.
- •You are taking any other medications, such as dietary supplements, that could affect the outcome of the study
研究组 & 干预措施
Fish oil
Active Comparator
干预措施: Omega-3 Fatty acid (with SRP or OHI) (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
clinical attachment loss
时间窗: baseline, 8, 16, 28 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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