Platelet Rich Fibrin Combined With 1.2% Atorvastatin Gel in Treatment of Mandibular Degree 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
- 82
- 试验地点
- 2
- 主要终点
- . Radiographic bone fill assessed in percentage
研究概览
简要总结
The present study was designed to explore the effectiveness of PRF combined with 1.2% ATV gel in treatment of mandibular degree II furcation defects in comparison to PRF and open flap debridement (OFD) alone.
详细描述
Background: A variety of regenerative materials have been tried since many years for the treatment of furcation defects. Platelet-rich fibrin (PRF), a pool reservoir of platelet concentrate with growth factors and Atorvastatin (ATV), a potent member of statin group are known to promote periodontal tissue regeneration. The aim of the present study is to explore the effectiveness of PRF combined with 1.2% ATV gel in treatment of mandibular degree II furcation defects in comparison to PRF and open flap debridement (OFD) alone.
Methods: Eighty two mandibular furcation defects were treated with either OFD alone (Group 1), OFD with PRF (Group 2), and OFD with PRF+1.2% ATV gel (Group 3).Clinical parameters like probing depth (PD), relative vertical clinical attachment level (RVCAL), relative horizontal clinical attachment level (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index (PI) were recorded at baseline and 9 months post-operatively. The radiological assessment of bone defect fill was done at baseline and 9 months, using computer-aided software.
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
- Double (Participant, Investigator)
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
- Relative vertical attachment level measured in mm(baseline to 9 months)
- plaque index(baseline to 9 months)
- probing depth measured in mm(baseline to 9 months)
- Relative horizontal attachment level measured in mm(baseline to 9 months)
- modified sulcus bleeding index(baseline to 9 months)
研究者
Dr. A R Pradeep
Professor and Head, Dept of Periodontology
Government Dental College and Research Institute, Bangalore