Dietary Supplementation With Low-Dose Omega-3 Fatty Acids Reduces Salivary TNF-α Levels in Patients With Chronic Periodontitis
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- change in levels of salivary TNF alpha
研究概览
简要总结
The investigators primary objective in this clinical intervention study, therefore, was to explore the impact of omega-3 PUFAs in conjunction with scaling and root planing on salivary markers (in patients with chronic periodontitis.
详细描述
Thirty systemically healthy subjects with chronic periodontitis were enrolled and randomly allocated into two groups. The control group (n=15) was treated with scaling and root planing (SRP)+placebo whereas the test group (n=15) was treated with SRP and dietary supplementation of low-dose omega-3 PUFAs (6.25 mg EPA and 19.19 mg DHA). Clinical parameters were taken at baseline, 1, 3 and 6 months following therapy. Saliva samples were obtained at the same time intervals and analyzed for tumor necrosis factor-α (TNF-α) and superoxide dismutase (SOD).
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
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with chronic periodontitis
- •had at least nine posterior teeth (not including third molars and teeth with bridges and crowns)
- •with 5-7 mm pocket depth
- •three teeth with 6 mm or more of probing attachment loss enrolled in the study
排除标准
- •patients were excluded on the basis of periodontal surgery within the last year;
- •SRP as part of initial periodontal therapy within the past 6 months;
- •history of diabetes, any diseases or disorders that compromise wound healing, any history of acute or chronic inflammatory disease,
- •any oral mucosal inflammatory condition (e.g., aphthous, lichen planus, leukoplakia, and oral cancer) and use of aspirin
- •other non-steroidal anti-inflammatory drugs or antibiotics within the last 6 months.
结局指标
主要结局
change in levels of salivary TNF alpha
时间窗: From baseline to 1, 3, 6 months
次要结局
- change in levels of salivary SOD(From baseline to 1, 3, 6 months)
研究者
İlker KESKINER
Assist.Prof.Dr.
Ondokuz Mayıs University