The Effect of Use of Dermal Fat Graft as a Barrier Membrane in Unilateral Alveolar Cleft Grafting. (A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of oronasal fistula
研究概览
简要总结
a study conducted to assess the use of dermal fat graft use as barrier membrane over grafted bone
详细描述
The study has two group in which the study will have in addition to the conventional bone grafting addition of dermal fat graft to protect the bone. The control will have just normal graft
The results are assessed using computed tomography to assess the quality of the grafted bone.
The Chisquare test was used to asses the results significance.
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)
盲法说明
double blinded
入排标准
- 年龄范围
- 9 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients having age range of 8-14ys who performed for 2ry alveolar cleft grafting at the CCC using adipose fat graft in conjunction with ACBG Boys or girls. Unilateral or bilateral cleft alveolus. Accepts Healthy Volunteers has not been entered.
排除标准
- •Younger patients requiring 1ry grafting. Older patients requiring 3ry grafting.
研究组 & 干预措施
study group
Dermal fat graft is added over the grafted bone in the alveolar cleft to protect the bone from resorption
干预措施: Addition of dermal fat graft as protection over bone graft (Procedure)
control group
Conventional procedure of alveolar cleft grafting
结局指标
主要结局
Incidence of oronasal fistula
时间窗: 6 months
assessment of incidence of recurrence of oronasal fistual after the surgical procedure clinically
次要结局
未报告次要终点
研究者
Yasser Mohamed Nabil Ahmed Khirat El Hadidi
principle investigator
Ain Shams University