NCT05971914进行中（未招募）不适用
Alveolar Cleft Hard- and Soft Tissue Reconstruction With an Autogenous Tooth Derived Particulate Graft
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Radiological volumetric measurements
研究概览
简要总结
The present study aims at clinical and radiographic evaluation of the safety and efficacy of Bonmaker ATB powder combined with a novel split thickness papilla curtain flap in the treatment of alveolar cleft defects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children with alveolar cleft
- •patient presented at least three deciduous teeth scheduled for extraction.
排除标准
- •major relevant clinical diseases,
- •systemic use of steroids,
- •current or previous intravenous bisphosphonate treatment,
- •acute infection at the operation site.
结局指标
主要结局
Radiological volumetric measurements
时间窗: 6 months
Volumetric measurements will be conducted after the healing period. On prealigned pre- and postoperative CBCT cross-sections, linear measurements and volumetric measurements will be taken parallel to a reference base to determine the width of the surgical area.
次要结局
- complications(1, 14, 30 days and 3 and 6 months after surgeries.)
- soft tissue healing(during the 6 months postoperatively)
研究者
Dr. Nagy Krisztián
Associate Professor
Semmelweis University
研究点 (2)
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