Autogenous Sticky Bone Plus Platelet-rich Fibrin Membrane Versus Xenograft With Collagen Membrane for Treatment of Posterior Atrophic Mandible (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in implant stability
研究概览
简要总结
Background: Teeth loss in the posterior mandible initiates residual ridge resorption, this causes difficulty in implant placement so ridge augmentation must be done either simultaneous with implant placement or in a staged approach Aim: To evaluate the effect of autogenous sticky bone with PRF membrane and xenograft with collagen membrane with simultaneous implant placement clinically on primary and secondary implant stability, and radiographically on bucco-lingual width gain, bone density and crestal bone loss
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with missing posterior mandibular teeth.
- •Horizontal bone defect with width < 5.5 mm.
- •Adequate zone of keratinized tissue
排除标准
- •Presence of infection or periapical lesions in adjacent teeth.
- •Medically compromised patients with a condition that affects the procedure.
- •Insufficient inter-arch distance.
- •Bruxism or clenching.
- •Alcoholism.
- •Heavy Smokers.
研究组 & 干预措施
Test Group
干预措施: autogenous sticky bone + PRF membrane (Other)
Control Group
干预措施: Xenograft + collagen membrane (Other)
结局指标
主要结局
Change in implant stability
时间窗: up to 6 months
Implant stability will be recorded immediately after placement (1ry stability) and after 6 months (2ry stability ) by using osstell device. The result is presented in form of ISQ value from 1 to 100, the higher the ISQ the higher the stability of implant
change in bucco-lingual bone thickness
时间窗: up to 6 months
All participants in the study will be advised to undergo CBCT before implant placement to measure bucco-lingual bone thickness, and again 7 days postoperatively and 6 months after implant placement to assess the following.
change in marginal bone level
时间窗: up to 9 months
At buccal, lingual, mesial, and distal sites will be evaluated radiographically from the shoulder of the implant to the alveolar crest. The mean marginal bone loss after the placement of implants will be calculated by subtracting baseline value from the values obtained at 6 and 9 months post implant placement
change in ridge width
时间窗: up to 6 months
Will be measured immediately and after 6 months, bone width will be measured for each implant at three levels (2, 5, and 10 mm from the alveolar crest) and the mean will be calculated for each implant at each time interval.
次要结局
- change in pain scores(up to 7 days)
- change in edema scores(up to 7 days)
- change in bone density(up to 6 months)