NCT00285714Unknown不适用
An Analysis of the Clinical Applicability of a Three-Dimensional Imaging Platform Used to Register the Influence of Orthognathic Surgery on Facial Hard and Soft Tissue in Patients With Congenital Maxillofacial Deformities.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 6
- 主要终点
- All changes (volumetric, linear or angular) of facial hard and soft tissue caused by orthognathic surgery at 1 months, 6 months, 12 months and 24 months.
研究概览
简要总结
The primary objective of this clinical trial is to assess the influence of orthognathic surgery on facial soft tissue, such as changes (volume, linear, angular) of facial hard and soft tissue, in three dimensions, so enabling the setup of 3D normative value tables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Dysgnathic deformity
- •Caucasian
- •> 15 years
- •No history of orthognathic surgery
- •Informed Consent
排除标准
- •< 15 years
- •History of Orthognathic surgery
- •Not Caucasian
结局指标
主要结局
All changes (volumetric, linear or angular) of facial hard and soft tissue caused by orthognathic surgery at 1 months, 6 months, 12 months and 24 months.
次要结局
- All postoperative changes in functionality at 1 year
- patients' satisfaction of facial proportions at 1 year
- surgeons' satisfaction of the 3D planning platform at 1 month
研究者
研究点 (6)
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