Effect of Local Application of Platelet-rich Fibrin Scaffold Loaded With Simvastatin on Peri-implant Bone Changes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- The measurement of bone thickness
研究概览
简要总结
ACKGROUND: Simvastatin (SIM), a pharmacological drug used for hypercholesterolemia, has been found to have pleotropic effects on bones. Simvastatin together with the appropriate carrier may decrease bone loss around implants.
PURPOSE: To compare the long term effects of autologous PRF alone, and PRF loaded with SIM on peri-implant bone changes and implant stability in patients undergoing implant rehabilitation.
MATERIALS AND METHODS: A randomized controlled split-mouth studyincluding 8 males between the ages of 45-60 years. Each patient received two implants, one on each side of the arch. One side was treated with PRF alone and the other side with PRF +Simvastatin, at the time of Osteotomy. A cone-beam CT was used to evaluate bone changes around the insertion of implant sites atthree, six, and twelve months postoperatively. The secondary outcome included measuring implant stability using Ostell device at baseline and 3 months post insertion. To compare groups at different time periods, data was examined using a two-way (ANOVA) analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 接受健康志愿者
- 是
入选标准
- •patients with a partially edentulous mandible indicated for rehabilitation with implant prostheses,
- •any extractions, or surgeries performed at least six months earlier.
排除标准
- •patients with systemic diseases affecting bone quality or resorption
- •temporomandibular joint dysfunction,
- •severe attrition or parafunctional habits,
- •patients undergoing radiotherapy or chemotherapy,
- •heavy smokers,
- •vulnerable groups such as psychologically unstable patients
研究组 & 干预措施
PRF alone
干预措施: Simvastatin (Drug)
PRF in addition to Simvastatin
干预措施: Simvastatin (Drug)
结局指标
主要结局
The measurement of bone thickness
时间窗: After 12 months of the osteotomy and application of Simvastatin
Measuring unit in millimeters , measuring device is CBCT software
次要结局
未报告次要终点
研究者
Sara Fikry El Shafei
Principal investigator
British University In Egypt