The Influence of Cortical Bone Perforation on Guided Bone Regeneration in Humans: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- The amount of vital bone formation by histomorphometric analysis after cortical bone perforation
研究概览
简要总结
The purpose of this randomized clinical trial was to evaluate the effect of cortical bone decortication on the angiogenesis and osteogenesis of augmented ridge by GBR.
详细描述
Background: The purpose of the current study was to evaluate the effect of cortical bone perforation on angiogenesis and osteogenesis of augmented ridge by guided bone regeneration.
Methods: Fourteen patients (mean age: 52) who were in need of dental implants at areas with osseous defects in the mandible were selected. In the test group (n=7), alveolar cortical bone at the area of regeneration was perforated using a #2 high speed round bur. No decortication of cortical bone was performed in the control group (n=7). Subsequently, defects were augmented by guided bone regeneration using resorbable membrane and bovine bone. After a healing period of 7 months, implant sites were created and trephine cores harvested for histological and histomorphometric analysis of the grafted areas.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria were presence of atrophic mandibular ridges with bucco-lingual width ranging between 2-5 mm, as measured on serial sections of a computerized axial tomography (CAT) scan.
排除标准
- •Exclusion criteria included patients with diabetes, osteoporosis or other metabolic disorders, smokers, pregnant patients and patients who had any systemic or local factors that would inhibit normal wound healing process.
结局指标
主要结局
The amount of vital bone formation by histomorphometric analysis after cortical bone perforation
时间窗: 7 months
次要结局
未报告次要终点
研究者
seyedamir Danesh Sani
Principal Investigator, postgraduate resident
Mashhad University of Medical Sciences