Evaluation of Omega-3 Polyunsaturated Fatty Acids Plus Low-dose Aspirin Daily Supplementation in Non-surgical Therapy to Treat Generalized Aggressive Periodontitis: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in Probing Depth
研究概览
简要总结
The aim of this randomized controlled clinical trial of superiority will be to evaluate the effect of 3 g of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily supplementation over a period of 180 days as adjunct to non-surgical therapY of patients with generalized aggressive periodontitis. Probing depth, clinical attachment level, gingival index and concentration of microorganisms and cytokines at baseline, 3, and 6 12 months after the procedure will be evaluated.
详细描述
The study methodology is according to CONSORT-STATEMENT 2010 for randomized controlled clinical trials.
Study Design The study is designed as a prospective, interventional, parallel, blinded, randomized, controlled clinical trial of superiority.
Source of data The population of this study will be recruited among patients referred to the Science and Technology Institute - ICT- São José dos Campos, College of Dentistry. Patients will fill a healthy history questionnaire to ensure that they are medically qualified for participate in this study. Based on the power calculation for this study, a population of 38 patients will be included. Considering α of 5% and 10% β-type error (90% power) to detect a difference of at least 1 mm in probing depth reduction of pockets ≥ 5 mm between groups, for a standard deviation of 0.94 from a previous study evaluating different antimicrobials in the treatment of GAgP (Xajigeorgiou et al., 2006), 19 patients will be needed in each group.
Clinical Parameters All clinical parameters will be assessed by a single blinded, trained and calibrated examiner (CFA) before periodontal therapy (baseline) and at 3 and 6 months after using a manual probe. Measurements will be done at six sites per tooth (mesiobuccal, buccal, disto-buccal, distolingual, lingual, and mesiolingual) in all teeth, except third molars.
The following clinical parameters will be evaluated: 1) Full-mouth plaque index (FMPI); 2) Bleeding on probing (BoP); 3) Probing depth (PD): distance from the bottom of sulcus/pocket to gingival margin; 4) Gingival recession (GM): distance from the free gingival margin to cement-enamel junction (CEJ); 5) Clinical attachment level (CAL): distance from bottom of sulcus/pocket to the CEJ. The CEJ will be identified by careful probe on cervical area.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of GAgP (AAP, 1999);
- •presence of ≥20 teeth;
- •presence of ≥ 6 sites presenting PD ≥ 5mm with bleeding on probing (BOP) and ≥2 sites with PD ≥7mm (including incisors and first molars, in addition to other two non-contiguous teeth);
- •good general health;
- •agree to participate in the study and sign a written informed consent. All subjects will be individually informed about the objectives, probable risks and benefits of the protocol treatment (according to Resolution nº196 of October 1996 and to the Professional Code of Dental Ethics - 179/93).
排除标准
- •pregnancy or lactating;
- •suffer from any systemic disease (e.g. cardiovascular disorders, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease;
- •took antimicrobials in the previous 6 months;
- •taking long-term anti-inflammatory drugs;
- •previous periodontal treatment within the last 12 months;
- •smoker ≥ 10 cigarettes.
研究组 & 干预措施
Control group
In this group (n = 19), patients will take placebo pills and full-mouth ultrasonic debridement will be performed to treat diseased sites.
干预措施: Placebo (Other)
Control group
In this group (n = 19), patients will take placebo pills and full-mouth ultrasonic debridement will be performed to treat diseased sites.
干预措施: Full-mouth ultrasonic debridement (Procedure)
Test Group
In this group (n = 19), patients will take 3 g of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily over a period of 180 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
干预措施: Omega-3 polyunsaturated fatty acids (Dietary Supplement)
Test Group
In this group (n = 19), patients will take 3 g of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily over a period of 180 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
干预措施: Aspirin (Drug)
Test Group
In this group (n = 19), patients will take 3 g of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily over a period of 180 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
干预措施: Full-mouth ultrasonic debridement (Procedure)
结局指标
主要结局
Change in Probing Depth
时间窗: Baseline, 3 and 6 months
Evaluate the difference between baseline and 6 months PD measures.
次要结局
- Change in Clinical Attachment Level(Baseline, 3 and 6 months)
- Change in Bleeding on Probe(Baseline, 3 and 6 months)
研究者
Mauro Pedrine Santamaria
PhD Adjunt professor
Universidade Estadual Paulista Júlio de Mesquita Filho