Evaluation of the Effects of Orthognathic Surgeries on the Temporomandibular Joint Using a Mandibular Movement Analyzer Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Three-Dimensional Condylar Displacement
研究概览
简要总结
Condylar position and mandibular motion assessment with digital facebows Arcus Digma III before and after orthognathic surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Age between 18 and 45 years (skeletally mature patients). Severe dentofacial deformity requiring combined orthodontic and orthognathic surgical treatment (e.g., Le Fort I osteotomy, bilateral sagittal split osteotomy, or bimaxillary procedure).
- •Presurgical orthodontic preparation completed or near completion. Signed written informed consent prior to study enrollment. Ability and willingness to attend all scheduled preoperative and postoperative follow-up visits.
排除标准
- •History of previous orthognathic or major craniofacial surgical interventions. Congenital craniofacial anomalies, cleft lip and/or palate, or genetic syndromes affecting the musculoskeletal or facial skeleton.
- •Pre-existing severe degenerative temporomandibular joint disease (e.g., advanced osteoarthritis, idiopathic condylar resorption, or ankylosis).
- •Systemic rheumatologic, autoimmune, or connective tissue disorders affecting bone and joint metabolism (e.g., rheumatoid arthritis, lupus).
- •Active neurological or neuromuscular disorders affecting jaw movement or motor control.
- •Current use of medications significantly altering bone metabolism or neuromuscular function (e.g., chronic systemic corticosteroids, antiresorptive agents).
- •Severe unmanaged bruxism or acute trauma to the maxillofacial region
研究组 & 干预措施
Orthognathic Surgery Cohort
Adult patients diagnosed with dentofacial deformities undergoing combined orthodontic and orthognathic surgical treatment (e.g., bilateral sagittal split osteotomy, Le Fort I osteotomy, or bimaxillary surgery). Participants undergo preoperative and postoperative clinical and functional assessments of the temporomandibular joint (TMJ), including mandibular motion, condylar position analysis, and evaluation of temporomandibular signs and symptoms.
结局指标
主要结局
Change in Three-Dimensional Condylar Displacement
时间窗: Baseline (preoperative, within 4 weeks prior to surgery) and at 6 months postoperatively
Change in Mandibular Maximum Range of Motion
时间窗: Baseline (preoperative, within 4 weeks prior to surgery) and at 6 months postoperatively
次要结局
未报告次要终点