Alveolar Cleft Hard- and Soft Tissue Reconstruction With an Autogenous Tooth Derived Particulate Graft
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
- 1
- 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.
研究组 & 干预措施
Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap
Extracted deciduous teeth were prepared immediately after removal according to the manufacturer's instructions with the Bonmaker® device. Ready to use autogenous tooth bone graft (ATB) was mixed with fibrin glue in 3D planned and printed plastic cuvettes to obtain a sticky graft closely matching the shape and extent of the bony defect. The preshaped sticky ATB graft was inserted and compacted in the cleft defect. Subsequently, the tension-free split thickness flap was repositioned by shifting all buccal surgical papillae mesially to the adjacent or the second adjacent interproximal space, depending on the horizontal extent of the cleft.
干预措施: Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap (Procedure)
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