Evaluation of Modified Le Fort I Osteotomy for Treating Cleft Lip and Palate Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Alveolar Gap Measurement
研究概览
简要总结
Nine adults with Angle class III relation and persistent alveolar bone defect due to CL/P deformity were included. SLF-1 maxillary advancement was performed. Lateral profile analysis and alveolar bone defect volume were assessed before and after the surgery.
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
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of a maxillary skeletal deformity requiring correction
- •Presence of an alveolar cleft deformity not previously treated at the mixed dentition stage.
- •Patients having an alveolar cleft previously treated but a residual deformity is still present.
排除标准
- •Class 1 occlusion
- •Dental malocclusion not associated with dentofacial deformities.
- •Medical contraindication to general anesthesia
- •Psychological instability
研究组 & 干预措施
adults with Angle class III relation and persistent alveolar bone defect due to CL/P deformity
干预措施: segmental Le Fort I (SLF-1) osteotomy (Procedure)
结局指标
主要结局
Alveolar Gap Measurement
时间窗: 6 months
CBCT DICOM images of the patient's scan were imported into 3D Slicer software (BWH, USA). Volume rendering was calculated based on selection of region between the base of the nose superiorly, and edges of the alveolar cleft inferiorly, posteriorly, anteriorly, and on both sides. Segmentation of air present in this region was done, and exported in Standard Tessellation Language (stl) file format. The volume of this file was calculated to give an estimate of volume of the alveolar defect, using Meshmixer™ Version 3.5.474 (Autodesk®, California, USA). 6 months' postoperative CBCT and preoperative CBCT. were compared to determine the amount of change.
次要结局
- amount of planned maxillary advancement compared to actual amount of advancement achieved after the operation(6 month)