Simulation of Facial Soft Tissue in Orthognathic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Validation of the predictions provided by the digital face model (SPOC).
研究概览
简要总结
Orthognathic surgery consists of rebalancing the position of the jaws, taking into account functional criteria (tooth engagement, tooth/lip ratio, breathing, etc.) and aesthetic criteria. It has become much more accurate in recent years thanks to the advent of osteosynthesis plates and the contribution of three-dimensional imaging. Three-dimensional imaging makes it possible to simulate fairly accurately the surgical procedures and bone displacements required. However, the effect of these bone displacements on the soft tissues (skin, subcutaneous tissue, muscles) does not make it possible, with today's digital tools, to simulate the final aesthetic result and in particular to anticipate the sometimes significant postoperative changes to the face. Many patients are worried about these post-operative morphological changes and would like to have a precise idea of how they will look after surgery. Being able to offer them, before surgery, a visual solution simulating the final aesthetic appearance would be essential in this respect.
The aim of the study is to validate the predictions provided by the digital face model on a series of patients scheduled for orthognathic surgery by comparing the simulation of the morphological result of the operation, provided by our algorithm (SPOC), with the actual result assessed on a scan taken 6 months after the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 ;
- •Patients who have been informed of the study and who have freely given their informed consent to participate in the study;
- •Patient undergoing isolated mandibular or maxillary orthognathic surgery, or maxillo-mandibular surgery with or without genioplasty for any indication (occlusal disorder, sleep apnoea syndrome, functional joint disorder, etc.);
- •Patient covered by a French social security scheme
排除标准
- •Patient with maxillary disjunction ;
- •Patients with facial malformations;
- •Pregnant or breast-feeding patient;
- •Patient under guardianship;
- •Patients who do not understand French;
- •Patients under court protection
- •No pre- or postoperative CT scan or CT scan that cannot be used
- •Surgery, trauma, progressive infection or cosmetic injection on the face after orthognathic surgery and before the postoperative scan
结局指标
主要结局
Validation of the predictions provided by the digital face model (SPOC).
时间窗: 6 months after orthganthic surgery
Correlation of morphological result simulation of surgery, provided by our algorithm (SPOC), with the actual result assessed on a scan taken 6 months after the surgery.
次要结局
未报告次要终点