Effect of Local Application of Platelet-Rich Fibrin Scaffold Loaded With Simvastatin Versus Bone Powder on Peri-Implant Bone Changes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Changes in crestal peri-imlant Bone
研究概览
简要总结
This study is conducted A- To investigate that PRF loaded with osteopromotive pharmacological drug can be a great aid in implant rehabilitation, and whether it could be a replacement for the other high price bone graft materials or not.
This will be done through:
- Measuring bone changes around the implant by cone beam
- Measuring change in bone density around the implants
B- Evaluate the effect of statins on osteoblasts activity and expression of various osteogenic products in vitro.
详细描述
Twenty four patients requiring rehabilitation by immediate implantation in an extraction socket were recruited for this study. The Patients were divided into three groups (n=8), For the first group; immediately after extraction, PRF alone was added into the extraction socket prior to implant insertion. For the second group, PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion. For the third Group; PRF + Bone powder are inserted into the extraction site before implant insertion. A conebeam CT was used to evaluate the effect on bone changes and bone density around implant sites, for every patient in all implant groups immediately after the surgery and at follow-up time. In vitro experiment: isolation of human Adipose mesenchymal stem cells (hAd-MSCs), characterization and osteogenic differentiation will be done. The cells were divided into two groups one control group and the other statin group. Osteogenic markers were measured in both groups and statistical analysis performed
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Badly Broken Down Tooth requiring extraction
- •Medically Free
- •Any other procedures or surgeries were performed 6 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 like psychologically unstable patients.
研究组 & 干预措施
PRF
PRF alone was added to extraction site prior to implant insertion
干预措施: Simvastatin (Drug)
SIM+ PRF
PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion
干预措施: Simvastatin (Drug)
BO+ PRF
PRF + Bone powder are inserted into the extraction site before implant insertion.
干预措施: Simvastatin (Drug)
结局指标
主要结局
Changes in crestal peri-imlant Bone
时间窗: 12 months
Radiographic evaluation of crestal bone changes around the studied implants
次要结局
未报告次要终点