Evaluation of Adjunctive Effect of 1% Metformin To Platelet Rich Fibrin For Mandibular Class II Furcation Defects: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Radiographic bone fill assessed in percentage
研究概览
简要总结
The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone.
详细描述
Background: For improving efficacy and outcomes of regenerative therapy for furcation defects, various materials has been investigated in addition to access therapy. Platelet-rich fibrin (PRF) having concentrated growth factors and cytokines and Metformin (MF), an efficacious member of biguanide group are known to enhance periodontal regeneration. The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone.
Methods: This randomized trial was conducted on 75 patients with mandibular class II furcation defects. Defects were surgically treated with either access therapy alone (Group 1), access therapy+PRF (Group 2), and access therapy+ PRF+1% MF (Group 3). Clinical parameters like probing depth (PD), relative clinical attachment level {vertical (RVCAL) and horizontal (RHCAL)}, modified sulcus bleeding index (mSBI) and site specific plaque index (PI) were evaluated at baseline and 9 months post-operatively. Radiological assessment of bone defect fill was done at baseline and 9 months.
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
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Buccal degree II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD) ≥ 5mm and horizontal ≥ PD 3mm after phase I therapy i.e, scaling and root planing (SRP);
- •No history of antibiotic or periodontal therapy in the preceding 6 months.
排除标准
- •Aggressive periodontitis patients
- •Systemic conditions known to affect the periodontal status;
- •Medications known to affect the outcomes of periodontal therapy;
- •Hematological disorders and insufficient platelet count (<100,000/mm3);
- •Pregnancy/lactation;
- •Smoking and tobacco use in any form
- •Immunocompromised individuals;
- •Those having unacceptable oral hygiene (plaque index [PI] >1.5).
- •Teeth with furcation involvement, non-vital teeth, and carious teeth indicated for restorations and mobility of at least grade II were also excluded.
结局指标
主要结局
Radiographic bone fill assessed in percentage
时间窗: baseline to 9 months
assessed in percentage
次要结局
- modified sulcus bleeding index(baseline to 9 months)
- plaque index(baseline to 9 months)
- probing depth measured in mm(baseline to 9 months)
- Relative vertical attachment level measured in mm(baseline to 9 months)
- Relative horizontal attachment level measured in mm(baseline to 9 months)
研究者
Dr. A R Pradeep
Professor and Head, Dept of Periodontology
Government Dental College and Research Institute, Bangalore