Clinical and Radiographic Evaluation of Low Sagittal Medial Ramus Osteotomy for Treatment of Skeletal Class II and Class III Malocclusion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 11
- 主要终点
- Number of Participants with Unfavorable Osteotomy Split ("Bad Split")
研究概览
简要总结
This prospective clinical trial aims to evaluate the clinical and radiographic outcomes of the low sagittal medial ramus osteotomy-a technical modification of the conventional sagittal split osteotomy (SSO)-for treating patients with skeletal Class II and Class III malocclusions.
Standard sagittal split osteotomies carry risks of complications, including unfavorable osteotomy propagation (bad splits) toward the condyle, ramus fragmentation, lingual interference of the distal segment, and inferior alveolar nerve (IAN) injury. To minimize these risks, this study utilizes a modified medial cut positioned low (below the lingula in an area with adequate marrow space) and short (terminating anterior to the lingula). This design aims to prevent osteotomy extension into the condylar region and eliminate lingual interference during segment repositioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with skeletal Class II or Class III malocclusion requiring mandibular orthognathic surgery.
- •Age range from 18 to 45 years old.
- •Systematically healthy patients classified as ASA physical status I or II (American Society of Anesthesiologists)
排除标准
- •Patients with a pre-existing history of inferior alveolar nerve (IAN) sensory impairment.
- •Patients with active or severe degenerative joint disease (DJD).
- •Patients with a prior history of orthognathic surgical procedures.
- •Patients presenting with systemic diseases or conditions known to compromise normal bone healing.
研究组 & 干预措施
Low Sagittal Medial Ramus Osteotomy Group
Patients undergoing orthognathic surgery using the low sagittal medial ramus osteotomy modification. The medial osteotomy cut is initiated slightly above the mandibular occlusal plane, positioned low (below the lingula in an area with adequate marrow space) and short (terminating anterior to the lingula and retrolingual fossa) to achieve 3D mandibular repositioning guided by CAD/CAM virtual surgical planning.
干预措施: Low Sagittal Medial Ramus Osteotomy (Procedure)
结局指标
主要结局
Number of Participants with Unfavorable Osteotomy Split ("Bad Split")
时间窗: Intraoperative (during the surgical procedure)
Intraoperative evaluation of the occurrence of unfavorable osteotomy propagation (e.g., condylar neck fracture, ramus fragmentation, or buccal/lingual plate fracture) during the sagittal split procedure, assessed via direct visualization and manual palpation.
次要结局
- Change from Baseline in Inferior Alveolar Nerve (IAN) Conduction Latency via TSSEP(Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively)
- Number of Participants with IAN Entrapment in the Proximal Segment(Intraoperative (during the surgical procedure))
- Incidence of Distal Segment Lingual Bony Interference(Intraoperative (during the surgical procedure))
- Condylar Position within the Glenoid Fossa via Panoramic Radiography(Postoperative Day 7 (within the first week postoperatively))
- Skeletal Stability and Surgical Movement Outcome(3 months postoperatively)
- Change from Baseline in SNB Angle via Lateral Cephalometry(Baseline (preoperative) and 3 months postoperatively)
- Change from Baseline in Inferior Alveolar Nerve (IAN) Peak Amplitude via TSSEP(Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively)
- Change from Baseline in Linear Pogonion Advancement (Pog-NB Distance) via Lateral Cephalometry(Baseline (preoperative) and 3 months postoperatively.)
- Frequency of Complete Bony Bridging at the Osteotomy Site via 3D CT Scan(6 months postoperatively.)
- Presence of Condylar Bony Alterations via 3D CT Scan(6 months postoperatively)
研究者
omar abdelhamid elbana
Assistant Lecturer, Oral and Maxillofacial Surgery Department, Faculty of Dental Medicine
Al-Azhar University