Clinico - radiographic evaluation of 1% Alendronate gel with platelet rich fibrin in surgical Treatment of mandibular molar grade-ii furcation defect: aRandomized clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- radiograpgic outcome
研究概览
简要总结
Aim & objective of this study is to evaluate clinically & radiographically; efficacy of 1% Alendronate gel in combination with PRF (prf + aln) & PRF alone in the treatment of grade ii furcation defects. 30 sample size will be included: sample will be divided into two groups (1) prf + aln (2) aln alone: after flap reflection & debridement investigational product will be placed in the furcation area & suture will be taken: clinical assessment will be done at 0,1,6 month, radiographic assessment at 0,6 month: collected data will be analysed using chi squre test
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Grade II furcation defects in mandibular first and second molars with a radiolucent furcation area on an intraoral periapical radiograph (IOPA) With probing pocket depth (PPD) ≥ 5mm and probing depth horizontal (PD) ≥ 3mm after etiotrophic phase i.e., scaling and root planing (SRP).
排除标准
- •patient with known systemic conditions which affects the periodontal status known medications which affect periodotal therapy outcomes allergy to bisphophonates or history of their systemic use.
结局指标
主要结局
radiograpgic outcome
时间窗: preoperatively one & six months postoperatively
Plaque index
时间窗: preoperatively one & six months postoperatively
Relative vertical attachment level
时间窗: preoperatively one & six months postoperatively
Relative horizontal attachment level
时间窗: preoperatively one & six months postoperatively
Probing depth
时间窗: preoperatively one & six months postoperatively
次要结局
- radiographic evaluation with periapical radiograph(baseline & 6 month postoperatively)