Combination of Bone Marrow Concentrate and Iliac Cancellous Bone Graft in Alveolar Cleft Grafting: a Clinical & Radiographic Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- bone volume
研究概览
简要总结
The aim of this study will be to analyze the newly formed bone volume and density, 6 months after alveolar cleft grafting using iliac cancellous bone graft, with and without bone marrow concentrate.
详细描述
Twelve patients with unilateral alveolar cleft will be enrolled in this randomized comparative study.
The patients will be divided into two groups, the control (group A) who received illiac cancellous bone graft and study group who received a combination of bone marrow concentrate and illiac cancellous bone graft (group B).
Cone Beam CT (CBCT) images will be done prior to surgery to asses preoperative alveolar defect volume. Six months postoperative CBCT images will be done and postoperative newly bone formed volume and density will be evaluated and bone formation ratio (BF%) will be calculated as follows: BF% = (formed volume/alveolar defect) × 100%.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from maxillary alveolar cleft
- •Patient with Primary, complete cleft lip
排除标准
- •Syndromic cases will be excluded
- •Previous operated cases
研究组 & 干预措施
Bone marrow concentrate
Bone marrow concentrate combined with Autogenous bone graft
干预措施: bone marrow concentrate alveolar cleft grafting (Procedure)
autogenous bone graft
grafting with autogenous bone graft
干预措施: Autogenous alveolar grafting (Procedure)
结局指标
主要结局
bone volume
时间窗: six months postoperative
V= (A1xT) + ( A2 xT) + …….+ (An xT) where: V= volume A= area T= thickness of the axial C.T slice N=number of slices
次要结局
- bone density(six months postoperative)
- bone formation ratio(six months postoperative)
研究者
Alshaimaa Ahmed shabaan
associate professor in oral & maxillofacial Surgery Department
Fayoum University