Accuracy of Maxillary Repositioning During Orthognathic Surgery: a Prospective Observational Descriptive Study in Annecy Genevois Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Distribution of the translational and rotational shifts of the maxilla between planning and realization
研究概览
简要总结
Orthognathic surgery aims to correct jaw position taking into account esthetic and functional criteria (dental occlusion, lip position, breathing...). These surgeries are planned using clinical, radiological and dental cast data. The result of this planning are occlusal splints. Orthognathic surgery had improved in the last decade with 3 dimensions computerized tomography scan (3D CT-Scan) planning and osteosynthesis implants. However the accuracy of the operative results compared to the planned ones has rarely been measured.
详细描述
Orthognathic surgery aims to correct jaw position taking into account esthetic and functional criteria (dental occlusion, lip position, breathing...). These surgeries are planned only after the end of the growing period and in association with orthodontics. It is necessary to wait the end of facial growth to expect a stable result especially concerning mandibular. The age limit seems to be around 15 to 16 years old for retromandibular deformities and around 18 years old for premandibular deformities.
These surgeries are planned using clinical, radiological and dental cast data. Occlusal splints are made using all these results; these occlusal splints are used during the orthognathic surgery to maintain bones in the planned position.
Since 1993, a navigation system (Orthopilot™) is used, which allow to track jaw position, in real time, with an accuracy around one millimeter and one degree, during orthognathic surgery. This system is routinely used for condyle repositioning after mandibular sagittal split osteotomies; but it is also useful for maxillary navigation and positioning.
The investigator propose to measure the accuracy of the operative results compared to the planned ones, using the Orthopilot™ system.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients needing orthognathic surgery with mobilization of the maxilla via a Le Fort I osteotomy, alone or associated to a mandibular osteotomy, whatever the indication (poor occlusion, sleep apnea, temporo-mandibular dysfunction...)
- •patient over 16 years old
- •having not expressed any opposition to the collection of his/her personal data for this study (patient him/herself or holder of parental authority in case of patients younger than 18)
排除标准
- •pregnancy
- •patients deprived of liberty
- •protected adult
- •patients needing maxillary disjunction
结局指标
主要结局
Distribution of the translational and rotational shifts of the maxilla between planning and realization
时间窗: during the surgery
Shifts will be quantified by 6 components (3 in rotation and 3 in translation) in a coordinate system given by Orthopilot™ navigation system. Accuracy of the surgical technic is evaluated by the distribution of the translational and rotational shifts of the maxilla between planning and realization, taking account conformity (when left/right translation is ≤ 1 mm, top/bottom and back/front translations are \< 2 mm, frontal rotation is ≤ 1° and axial and sagittal rotations are ≤ 2°), failure (when left/right, top/bottom and back/front translations are \> 2 mm, frontal, axial and sagittal rotations are \>4°), and non conformity (every other shifts).
次要结局
- Inter-incisal vector(during the surgery)