Post-surgical Stability in Mandibular Advancement Using Postsurgical Versus Presurgical Computer Guided Functional Appliance. (RANDOMIZED CLINICAL TRIAL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change from postoperative sagital position of the mandible at 12 months (skeletal stability)
研究概览
简要总结
The unstable condylar position in the glenoid fossa is a critical problem for postsurgical instability after mandibular advancement with subsequent mandibular relapse. The habitual forward occlusion in class II patients creates unstable condyle to glenoid fossa relationship making it hard for clinicians to determine the amount of mandibular advancement. Splint therapy is considered as a preoperative reversible nonsurgical condylar repositioning option in addition to its adjunctive effect for pain relief in TMJ symptomatic patients. To minimize this relapse, presurgical functional appliance therapy has been proposed and has shown promising outcomes.
详细描述
The aim of this study is to compare the effect of postsurgical versus presurgical computer guided functional appliance in relapse prevention after mandibular advancement surgery.
Surgical procedure:
- Owbgeser incision will be performed to expose the buccal and lingual aspects of the ramus angle region.
- CAD/CAM generated preoperative wafer will be placed on the lower arch dentition, the guide has an extension to guide medial, vertical, oblique cuts as well as screw holes for reference landmarks for proximal segment & tooth bearing segment.
- Drilling of all the reference landmarks on the proximal segment and locating medial, vertical, oblique cuts.
- Removal of guide, then BSSO is performed.
- The final wafer is placed, the guiding hole on the proximal segment will then be realigned with the previously drilled screw holes, fixation using mono cortical screws then drilling screw holes for plate fixation.
- Fixation of the osteotomy using 2.0 mm pre-bent mini plates.
- A positioning screw will be added to improve stability against rotational forces.
b-Functional appliance
Postsurgical computer guided functional appliance:
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)
盲法说明
Single blinding
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of the patient above 18 years
- •Patients in need of bilateral sagittal split osteotomy for mandibular advancement.
- •All patients are free from any systemic disease that may affect normal bone healing.
- •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
结局指标
主要结局
Change from postoperative sagital position of the mandible at 12 months (skeletal stability)
时间窗: immediately postoperative and 12 months later
Method of Measurement: Lateral cephalogram Unit of Measurement: mm
次要结局
- Assessment of condylar deviation(immediately postoperative and 12 months later)
研究者
Mohamed Mokhtar Elsayed Hafez
Assistant Lecturer of Oral and Maxillofacial Surgery
Cairo University