Platelet - Rich Fibrin Combined With 1.2mg Simvastatin for the Treatment of 3 - Wall Intrabony Defects in Chronic Periodontitis: 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
- 90
- 试验地点
- 1
- 主要终点
- The primary outcome measure of the study was defect depth reduction evaluated radiographically
研究概览
简要总结
The purpose of the present study was to investigate the efficacy of autologous Platelet rich fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the treatment of three wall intrabony defects in comparison to OFD alone.
详细描述
90 systemically healthy subjects were divided randomly into three groups (30 subjects in each group, per subject one site). Control group consisted of the sites treated with OFD and test groups sites were treated with OFD with autologous PRF or PRF with SMV. Site-specific plaque index (PI), sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and intrabony defect (IBD) depth reduction was measured at baseline and 9 month after surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with the diagnosis of chronic periodontitis
- •presence of three walled intrabony defects (IBD) ≥ 3 mm deep (distance between alveolar crest and base of the defect on intraoral periapical radiograph [IOPA])
- •interproximal probing depth (PD) ≥ 5 mm following scaling and root planing (SRP) in asymptomatic tooth
排除标准
- •Subjects, with the diagnosis of aggressive periodontitis,
- •with known systemic illness and taking medications known to affect the outcomes of periodontal therapy
- •insufficient platelet count (< 200,000/mm3),
- •pregnancy / lactation
- •use of any form of tobacco
- •unacceptable oral hygiene (if plaque index [PI] (Silness & Loe 1964) >1.5) after the reevaluation of phase I therapy
- •teeth with furcation defects
- •non-vital
- •mobility of tooth ≥ Grade II
研究组 & 干预措施
PRF and SMV Group
sites treated with Open Flap Debridement with Platelet Rich Fibrin along with Simvastatin
干预措施: Platelet rich fibrin and simvastatin (Drug)
PRF Group
sites treated with Open Flap Debridement with autologous Platelet Rich Fibrin
干预措施: Platelet rich fibrin (Biological)
OFD Group
sites treated with Open Flap Debridement i.e. conventional flap surgery
干预措施: Open Flap Debridement alone (Procedure)
结局指标
主要结局
The primary outcome measure of the study was defect depth reduction evaluated radiographically
时间窗: At baseline and 9 month after surgery
次要结局
- Plaque Index(At baseline and 9 month after surgery)
- Probing Depth(At baseline and 9 month after surgery)
- Relative Attachment Level(At baseline and 9 month after syrgery)
- modified Sulcul Bleeding Index(At baseline and 9 month after surgery)
研究者
Dr. A R Pradeep
Professor and Head of Department
Government Dental College and Research Institute, Bangalore