Alveolar Cleft Repair Using Osteoinductive Ceramics in Children With Unilateral Cleft Lip and Palate
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Bone volume
研究概览
简要总结
In this study, patients with unilateral cleft lip and palate are enrolled in a multicenter stepped wedge randomized trial ithat compares alveolar cleft closure using autologous bone harvested form the mandibular symphysis with an osteoinductive biphasic calcium phosphate putty.
详细描述
Rationale: Patients who undergo alveolar cleft grafting have to deal with postoperative pain and comorbidity due to harvesting of autologous bone.
Objective: To evaluate if using calcium phosphate based scaffolds for alveolar cleft grafting is as effective as the use of an autologous bone graft.
Study design: A 'stepped wedge' randomized controlled trial will be conducted by four centres.
Study population: Children between the ages of 8 to 12 years with a unilateral alveolar cleft.
Intervention: Study group undergoes alveolar cleft grafting with the use of a calcium phosphate based scaffold, the control group undergoes the same procedure, but with the use of an autologous chin bone graft.
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
- •unilateral alveolar cleft, early secondary alveolar cleft closure
排除标准
- •cleft lip and palate in a syndromic context
研究组 & 干预措施
Alveolar cleft repair using autologous bone from the mandibular symphysis
Control group
干预措施: Unilateral alveolar cleft repair (Device)
Alveolar cleft repair using a biphasic clacium phosphate putty
Study group
干预措施: Unilateral alveolar cleft repair (Device)
结局指标
主要结局
Bone volume
时间窗: 1 year postoperatively
One year postoperative residual bone volume
次要结局
- Postoperative pain(Day 1 to 7 postoperatively)
- Canine eruption(1 year postoperatively)
研究者
Nard Janssen
N.G. Janssen, Prinicpal Investigator
UMC Utrecht