Alveolar Cleft Reconstruction Using BMAC and Allograft vs Iliac Cancellous Bone: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- bone density
研究概览
简要总结
radiographic and clinical assessment of alveolar cleft grafting using Allograft mixed with BMAC compared to the standard protocol of anterior iliac crest cancellous bone grafting
详细描述
In the study group BMAC is collected after processing of bone marrow aspirated from anterior iliac crest using a stab incision and a specialized trocar with no surgical intervention at donor site. The BMAC will be mixed with allow graft and used for alveolar cleft grafting
In the control group the standard protocol for alveolar cleft grafting will be used which is surgical exposure of the anterior iliac crest and harvesting of cancellous bone particles.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •alveolar cleft patients at the mixed dentition phase
排除标准
- •patients with previous alveolar grafting intervention
结局指标
主要结局
bone density
时间窗: 6 months
Assessment of bone density at the grafting site from a CT scan using Hounsfild Unit (HU)
次要结局
- Bone gain(6 months)
- Postoperative donor site morbidity(1 month)
研究者
Ahmed Moustafa Ismail Abdelmaksoud
Assistant lecturer
Cairo University