A Comparative Study Between the Effect of Platelet-rich Fibrin and Concentrated Growth Factors on Osseointegration of Immediate Implants (a Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Marginal bone loss
研究概览
简要总结
This study will involve 14 patients with mandibular premolars indicated for extraction and immediate replacement. The patients will be randomly allocated into two groups and each patient will receive one implant. In Group A, a CGF membrane will be laid in the implant cavity. While in Group B, a PRF membrane will be laid in the implant cavity. Bone graft material will be applied to fill the empty parts of the socket.
Resonance frequency measurement will be done using the OSTELL device intraoperatively, at the 1st week and after 3 months. Cone-beam computed tomography will be done preoperatively, immediately following surgery, and after 3 months
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cooperative patients with good oral hygiene.
- •Patients having a history of mandibular premolars indicated for extraction and immediate replacement.
排除标准
- •Heavy smokers.
- •Parafunctional occlusal habits.
- •Uncontrolled diabetes.
- •History of chemotherapy or radiotherapy.
- •Hematological disorders that prevent either implantation or centrifugation.
- •Pregnancy.
- •The nee¬d for additional augmentation or previous augmentation of the same region.
- •Chronic periapical pathology
结局指标
主要结局
Marginal bone loss
时间窗: after 3 months
it will be assessed using CBCT
Change in Bone density
时间窗: immediately, after 3 months
The Patients will be asked to do CBCT immediately after surgery and after 3 months
Change in bone formation
时间窗: immediately, after 3 months
Amount of bone formed buccal and lingual to the implant will be assessed using CBCT
Change in implant stability
时间窗: immediately, at 1 week, at 3 months
Osstell instrument (Integration Diagnostics, Goteborg, Sweden) with Smartpeg™ (Integration Diagnostics, Goteborg, Sweden), a transducer suitable for implants will be used to assess stability of implants by RFA. ISQ (implant stability quotient) will be obtained from the measurement results. During measurement, the Smartpeg™ will be placed over the location of implant prosthesis and the Osstell probe will be approximated to it from the buccal, palatal, mesial and distal aspects of the implant giving four ISQ values. A mean ISQ for each implant is then calculated by averaging the four values. The ISQ values of the implants will be measured during the operation, at the first week and three months after the operation.
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University