The Effects of Docosahexaenoic Acid on Periodontitis in Adults: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in Pocket Depth (mm)
研究概览
简要总结
The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in the treatment of periodontitis in adults.
详细描述
- The primary aim of this study is to investigate the effect of docosahexaenoic acid (DHA; 2 gm/day) plus low dose aspirin (ASA 81 mg/day)compared to ASA alone on periodontitis over three months. Our hypothesis is that DHA plus ASA will improve periodontitis as measured by objective periodontal exam, including decreased pocket depth (mm), gingival index (0-3), plaque index (0-3) and bleeding on probing (yes/no) compared to ASA alone.
- Assess the effect of DHA and ASA exposure on markers of local inflammation, including gingival crevicular fluid (GCF) CRP, IL-1 beta and IL-6 three months after exposure to DHA plus ASA compared to ASA alone.
- Evaluate potential mechanisms through changes in the periodontal microbial flora which may occur as a result of exposure to DHA and ASA compared to ASA alone. Our hypothesis is that there will be a substantial post therapy change in the microbial flora of dental plaques, favoring bacteria associated with a lower systemic inflammatory state.
- Assess the effect of DHA and ASA exposure on markers of systemic inflammation, including serum C-Reactive Protein (CRP), interleukin-6 (IL-6) and vascular adhesion molecule (VCAM) compared to ASA. Our hypothesis is that there will be a decrease in serum CRP, IL-6 and VCAM three months after exposure to DHA plus ASA compared to ASA alone.
- Assess the effect of DHA and ASA exposure on markers of systemic bone turnover, including urine N-terminal telopeptide (NTx) compared to ASA. Our hypothesis is that there will be a decrease in urine NTx three months after exposure to DHA plus ASA compared to ASA alone.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age >40 years
- •>20 natural teeth (excluding third molars)
- •no orthodontic appliances
- •periodontitis defined as >4 teeth with pocket probing depths >5 mm
排除标准
- •pregnancy
- •severe chronic diseases
- •gastrointestinal bleeding
- •uncontrolled chronic diseases
- •autoimmune disorders
- •conditions requiring antibiotic prophylaxis
- •clopidogrel
- •antimicrobial therapy within 30 days
- •chronic use of non-steroidal anti-inflammatory drugs (other than aspirin)
- •omega-3 fatty acid use within 6 months
- •loose teeth
- •painful teeth
- •periodontal abscess
- •pocket depths >10 mm in >1 tooth
- •periodontal therapy within the past two years
- •allergy to aspirin
- •allergy to fish oil
- •allergy to corn oil
- •allergy to soybean oil
研究组 & 干预措施
Aspirin & Docosahexaenoic acid
Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months
干预措施: Aspirin (Drug)
Aspirin & Docosahexaenoic acid
Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months
干预措施: Docosahexaenoic acid (Drug)
Aspirin & Placebo
Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months
干预措施: Aspirin (Drug)
Aspirin & Placebo
Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months
干预措施: Placebo (for Docosahexaenoic acid) (Drug)
结局指标
主要结局
Change in Pocket Depth (mm)
时间窗: Baseline and 3 months
Pocket probing depth (PD) is the depth a dental probe can be inserted into a gingival pocket at a particular site (6 sites per tooth) measured in millimeters among teeth with PD greater than or equal to 5 mm (N=533 dental sites total).
次要结局
- Change in Gingival Index (0-3)(Baseline and 3 months)
- Change in Plaque Index (0-3)(Baseline and 3 months)
- Sites With Bleeding on Probing (Yes/no)(3 months)
- Gingival Crevicular Fluid High Sensitivity C-reactive Protein(Baseline and 3 months)
- Gingival Crevicular Fluid Interleukin-6(Baseline and 3 months)
- Gingival Crevicular Fluid Interleukin-1 Beta(Baseline and 3 months)
- Serum High-sensitivity C-reactive Protein(Baseline and 3 months)
- Serum High-sensitivity Interleukin-6(Baseline and 3 months)
- Serum Soluble Vascular Cell Adhesion Molecule(Baseline and 3 months)
- Urine N-Terminal Telopeptides(Baseline and 3 months)
研究者
Kenneth Mukamal
Associate Professor of Medicine
Beth Israel Deaconess Medical Center