Efficacy of Titanium prepared Platelet rich fibrin(T-PRF) scaffold loaded with Simvastatin versus Titanium prepared Platelet rich fibrin(T-PRF) on peri implant bone changes a randomized controlled clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Peri implant bone changes
研究概览
简要总结
The aim of the study is to compare the efficacy of Titanium-prepared Platelet rich Fibrin (T-PRF) scaffold loaded with Simvastatin and Titanium-prepared Platelet rich Fibrin alone on periimplant bone changes in patients undergoing implant placement using randomized control trial method. 16 systemically healthy patients will be randomly selected and 8 patients will be allotted to Group-A and remaining 8 will be allotted to Group-B. Group-A patients will receive T-PRF scaffold loaded with 1.2 mg Simvastatin in the osteotomy site during implant placement and Group-B patients will receive T-PRF scaffold alone during implant placement. CBCT will be taken for all the patients on Day-0 and at 6 months to assess the peri-implant bone changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy patients.
- •Partially edentulous patient with missing posterior teeth.
排除标准
- •Patients who are pregnant and lactating.
- •Patients with history of bone metabolic disease.
- •Patients currently taking drug that can influence bone metabolism.
- •Use of bisphosphonates in last 4 years.
- •Patients who are smokers.
结局指标
主要结局
Peri implant bone changes
时间窗: Day 0(The day of implant placement) and at 6 month
次要结局
- Mean crestal bone changes after implant loading(At 12th month)
研究者
DR Uma S
Meenakshi Ammal Dental College and Hospital