Assessment of Condylar Position Changes and TMJ Functions After BSSO Mandibular Setback, Low Medial vs High Medial Cut (Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 3D mandibular condylar position changes
研究概览
简要总结
This study hypotheses that using low medial cut osteotomy BSSO in mandibular setback can be an efficient and effective method to limit the bony segment interferences , decreasing muscles stripping during osteotomy ,decrease condylar torque and so securing preoperative condylar position during BSSO in comparison with using high medial cut BSSO.
详细描述
Research question:
Description of research question:
P: Population: Patients with facial skeletal deformity and need for mandibular setback using bilateral sagittal split osteotomy (BSSRO) alone or combined with lefort osteotomy.
I: Intervention: Patients with facial skeletal deformity and need and for mandibular setback using low medial cut osteotomy as modification of bilateral sagittal split ramus osteotomy (BSSRO).
C: Comparator: Patients with facial skeletal deformity and need and for mandibular setback using traditional high medial cut osteotomy bilateral sagittal split ramus osteotomy (BSSRO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of the patient between (18-60) years
- •Patients in need of mandibular setback using bilateral sagittal split osteotomy.
- •All patients are free from any systemic disease that may affect normal bone healing.
- •Patient with facial deformity will be treated with mandibular setback either mono or bimaxilary surgeries
- •Patient with facial deformity will be treated with mandibular setback either surgery first approach or orthofirst approach.
- •Sufficient dentition to reproduce the occlusal relationships
- •Patient's consent to participate
排除标准
- •Patients with any systemic disease that may affect normal healing
- •Intra-bony lesions or infections that may interfere with surgery.
- •Previous orthognathic surgeries.
- •Patients with all types of facial clefts
研究组 & 干预措施
mandibular setback using low medial cut ostetomy
mandibular setback using low medial cut ostetomy by keeping the cut ''low'' or close to the mandibular occlusal plane and ''short'' or terminating anterior to the lingula.
干预措施: mandibular setback using BSSRO (Other)
mandibular setback using high medial cut ostetomy
mandibular setback by placement of the medial ramus osteotomy cut 'high', just a few millimeters above the lingula, superior and lateral to the entrance point of the inferior alveolar nerve (IAN) into the mandibular foramen ,
干预措施: mandibular setback using BSSRO (Other)
结局指标
主要结局
3D mandibular condylar position changes
时间窗: Preoperative- 1-month postoperative - 6 months post operative
assessment of condylar position changes in millimetre using C.T.(axial ,coronal and sagital cut. ). 1. Axial condylar head long-axis angle (AHA): angle between the sagittal plane and the axial condylar head axis line 2. Axial condylar head position (AHP): perpendicular distance between the sagittal plane and the most medial point of the condylar head 3. Frontal condylar head long-axis angle (FHA): angle between the axial plane and the frontal condylar head long-axis line 4. Frontal condylar head position (FHP): perpendicular distance between the axial plane and most superior point of the condylar head 5. Sagittal condylar head long-axis angle (SHA): angle between the coronal plane and the sagittal condylar head long-axis line 6. Sagital condylar head position (SHP): perpendicular distance between the coronal plane and the most superior point of the condylar head
次要结局
- Assessment of changes in articular disc position(Preoperative , 6month postoperative)
研究者
Mahmoud Mohammed Mahmoud Hussein Alaswad
Principal Investigator
Cairo University