Evaluation of the Use of Omega-3 Pufa and Aspirin as Adjunctive Therapy in the Treatment of Smoker Patients With Stage Iii Periodontitis (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- change in probing depth
研究概览
简要总结
Background: Smoking reduces the effect of non-surgical periodontal therapy, a host modulation regimen consisting of omega-3 polyunsaturated fatty acids (ω-3 PUFA) supplementation with low-dose aspirin (ASA) with or without systemic doxycycline has been proposed to improve treatment response.
The Aim of the study is to explore the clinical effects of orally administered omega-3 PUFA and ASA with or without systemic doxycycline with periodontal debridement in treatment of smoker individuals with stage III periodontitis.
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
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smoker patients who smoke ≥ 10 cigarettes per day.
- •Stages III, Grades C periodontitis with at least one site with PD≥6 and CAL ≥5 mm.
排除标准
- •Scaling and root planning in the previous 6 months(that may confound the effect of treatment)
- •Antimicrobial therapy in the previous 6 months(that may confound the effect of treatment)
- •Chronic systemic diseases that may have an impact on periodontitis progression (diabetes mellitus).
- •Systemic diseases that may contraindicate aspirin or doxycycline taking (kidney and liver diseases)
- •Allergy to doxycycline
- •Long-term usage of medications that may impair periodontal health
- •Allergy to fish/seafood
研究组 & 干预措施
Omega-3 PUFA and Aspirin
干预措施: Omega-3 PUFA and Aspirin as adjunctive therapy to (SRP) (Other)
Omega-3 PUFA and Aspirin and doxycycline
干预措施: Omega-3 PUFA and Aspirin and doxycycline as adjunctive therapy to (SRP) (Other)
Conventional
干预措施: scaling and root planning (SRP) (Other)
结局指标
主要结局
change in probing depth
时间窗: baseline (t0) and at 3 (t1) and 6 months (t2)
the distance (in millimeters) from the gingival margin to the base of the gingival sulcus or periodontal pocket.
change in clinical attachment level
时间窗: baseline (t0) and at 3 (t1) and 6 months (t2)
the distance (in millimeters) from the cemento-enamel junction (CEJ) to the base of the periodontal pocket.
次要结局
- change in gingival index(baseline (t0) and at 3 (t1) and 6 months (t2))
- change in bleeding on probing(baseline (t0) and at 3 (t1) and 6 months (t2))