Effect of Omega 3 Fatty Acids on Chronic Periodontitis Patients in Postmenopausal Women: A Randomized Controlled Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- superoxide dismutase (SOD) activity in the gingival crevicular fluid
研究概览
简要总结
The study was aimed to investigating changes in periodontal parameters and superoxide dismutase activity after root surface debridement with and without Omega 3 fatty acids (ω-3 FAs) supplementation in postmenopausal women. Adjunctive Omega 3 fatty acids supplements reduce periodontal inflammation and improve the status of systemic enzymatic antioxidants in postmenopausal women.
详细描述
Fifty postmenopausal women with chronic periodontitis were divided randomly into two groups: Group 1 (n=25) were provided periodontal treatment in the form of scaling and root planing (SRP) plus placebo soft gelatin capsules while group 2 (n=25): patients were received SRP along with systemic administration of Omega 3 fatty acids. Clinical parameters and superoxide dismutase (SOD) activity in the gingival crevicular fluid were recorded at baseline, 3 and 6 months after therapy. The research has been conducted between July 2014 and June 2015. By the end of the study period, the Omega 3 treated group was able to achieve a greater mean probing pocket depth reduction, mean gain in clinical attachment level, as well as greater increase in SOD activity (P<0.01) compared to SRP 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
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with generalized chronic periodontitis (clinical attachment loss more than 30% of the teeth)
- •With probing pocket depth ≥ 5mm.
- •The age ranged between 45 and 60 years (To avoid the wide variation between individual cases in order to make the sample more homogeneous. Furthermore elderly patients above 60 years are usually not willing to have periodontal treatment).
- •Postmenopausal status for at least 1 year.
- •Presence of at least six teeth in the mouth.
排除标准
- •Any systemic disease that affect the periodontium.
- •Women who take anti-inflammatory drugs, antibiotics or vitamins within the previous 3 month.
- •Women who use mouth washes regularly
- •History of alcohol abuse
- •Participation in other clinical trials.
- •Obese women (Body mass index (BMI) ≥ 30).
结局指标
主要结局
superoxide dismutase (SOD) activity in the gingival crevicular fluid
时间窗: up to 6 months
Superoxide dismutase activity in the gingival crevicular fluid was carried out at baseline, 3 and 6 months post treatment.
次要结局
- Probing pocket depth(up to 6 months)
- Gingival index(up to 6 months)
- Clinical attachment level(up to 6 months)
- Plaque Index(up to 6 months)
研究者
Enas Elgendy
Ass. Prof.
October 6 University