Evaluation Of Clinical Periodontal Parameters And Pro-Resolvin Mediators Eicosapentanoic Acid (Epa) And Docosahexaenoic Acid (Dha) In Gingival Crevicular Fluid (Gcf) With Flax Seed Extract Gel As Local Drug Delivery In Treatment Of Stage 2 And Stage 3 Periodontitis Patients: A Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Plaque index score (PI), Gingival index score(GI), Probing pocket depth(PPD) and Clinical attachment level (CAL) and levels of Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA)
研究概览
简要总结
This study is a randomised controlled parallel group trial done to assess the pro-resolvin efficacy of indigenously formulated flax seed extract in the form of biodegradable gel when administered as a local drug delivery (LDD) agent in the treatment of stage 2 and stage 3 periodontitis by measuring the resolvins, EPA and DHA. The study will be conducted on out patients reporting to the Department of Periodontics, Dayananda Sagar College of Dental Sciences, Bengaluru. The primary outcome measures will be Plaque Index (PI), Gingival Index (GI), Probing pocket depth (PPD) and Clinical attachment level (CAL) and levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). The total sample size will be 26 with each group containing 13 subjects. The time period required for the study will be 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with Stage 2 and Stage 3 periodontitis in the age group of 25-60 years with a minimum of a total of 24 natural teeth.
- •Sites having pocket probing depth (PPD) of ≥5 mm and clinical attachment loss (CAL) of ≥3mm in the maxillary teeth.
排除标准
- •Patients suffering from any form of systemic diseases.
- •Patients currently on antibiotic/anti-inflammatory therapy, steroids or hormonal therapy within the past 6 months.
- •Patients with history of any dental therapy in the past 14 days.
- •Patients with oral abusive habits such as smoking , consumption of alcohol or tobacco or parafunctional habits (like bruxism and grinding of teeth)
- •Pregnant and lactating patients
- •Patients on a diet rich in omega fatty acids.
结局指标
主要结局
Plaque index score (PI), Gingival index score(GI), Probing pocket depth(PPD) and Clinical attachment level (CAL) and levels of Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA)
时间窗: Baseline, 1 month and 3 months for all the parameters
次要结局
- Allergic reactions, if any(Baseline)
研究者
Jisha S Raj
Dayananda Sagar College of Dental Sciences