Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Alveolar bone filling rate
研究概览
简要总结
Iliac crest autogenous bone graft is accepted as the most effective method for secondary alveolar cleft repair. However this method is associated with complications. As an alternative, mesenchymal stem cells associated with biomaterials have been used for the rehabilitation of the alveolar bone cleft of patients with cleft lip and palate. This is a RCT comparing mesenchymal stem cells obtained from autogenous deciduous dental pulp associated with biomaterials versus iliac crest autogenous bone graft for secondary alveolar cleft repair.
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
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •non syndromic unilateral cleft lip and palate;
- •age between 7 and 12 years;
- •to have the jaw aligned and ready to receive the graft.
排除标准
- •previous surgery to correct the alveolar cleft;
- •have the canine erupted before grafting;
- •incomplete orthodontic treatment;
- •incomplete CT scan documentation.
结局指标
主要结局
Alveolar bone filling rate
时间窗: 12 months
Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.
Serious adverse events
时间窗: 12 months
Serious adverse events resulting in death, life-threatening event, hospitalization, prolongation of existing hospitalization (for \> 24 hours), persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. Important medical event that may not result in death, be life threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon medical judgment, it may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Frequency of participants experiencing at least one serious adverse event.
次要结局
- Non serious adverse events(15 days; 3, 6 and 12 months)
- Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair(Bone tissue engineering)
- Alveolar bone filling rate(6 months)
- Patient-reported outcome (PRO, including appearance, fuction and quality of life)(pre surgery and 12 months)
- Position of the canine tooth and formation of dental root(12 months)
- Serious adverse events(15 days; 3 and 6 months)
研究者
Daniela Franco Bueno
Principal Investigator
Hospital Sirio-Libanes