Clinical, Volumetric and Densitometric Evaluation of Tissue Engineered (TE) Constructs for Secondary Alveolar Cleft Reconstruction (Short Term Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Assessment of changes in the bone volume at the grafted alveolar cleft site from the immediate postoperative to 6 months
研究概览
简要总结
Description of the research question
In children undergoing unilateral alveolar cleft reconstruction, would stem cells carried on collagen scaffold provide bone of a good quality and quantity if compared to autogenous bone grafting?
Objective of the study:
• Research hypothesis
The tissue engineered constructs will provide sufficient bone of a good quality and quantity if compared to autogenous bone graft in children undergoing unilateral alveolar cleft reconstruction.
- The objectives
The primary objective:
Assessment of bone volume (quantity) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.
The secondary objective:
Assessment of bone density (quality) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with maxillary unilateral alveolar clefts requiring reconstruction
- •Children free from any systemic disease that may affect normal healing of bone
- •Children in an age range (8-14) year.
- •Exclusion criteria
- •Bilateral alveolar clefts.
- •Cleft lip or palate not including the alveolus.
- •Immunocompromized patients.
- •Children who undergone previous bone grafting procedure for the alveolar cleft
排除标准
- 未提供
研究组 & 干预措施
tissue engineered group
autogenous bone marrow derived and cultured stem cells loaded on collagen matrix was implanted in the alveolar cleft in the study group (1st arm)
干预措施: tissue engineered group (Other)
autogenous bone graft group
autogenous cortico-cancellous bone graft harvested from the anterior iliac crest was implanted in the alveolar cleft of the control group (2nd arm)
干预措施: autogenous bone graft group (Procedure)
结局指标
主要结局
Assessment of changes in the bone volume at the grafted alveolar cleft site from the immediate postoperative to 6 months
时间窗: Immediate postoperative and after 6 months
Measuring the bone volume on CT scan
次要结局
- Assessment of changes in the bone density at the grafted alveolar cleft site from the immediate postoperative to 6 months(Immediate postoperative and after 6 months)
研究者
Walaa Kadry
principal investigator at Oral & Maxillofacial Surgery department, Faculty of Dentistry, Cairo University
Cairo University