NCT06850194招募中不适用
Evaluating the Efficacy of Vertical Ramus Osteotomy With Iliac Graft Versus Bilateral Sagittal Split Osteotomy for the Correction of Mandibular Deficiency in Skeletal Class II Cases Management. A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- skeletal stability
研究概览
简要总结
- Patients will be collected from faculty of dentistry
- bilateral vertical ramus osteotomy (VRO )with iliac graft group (group I):- 10 patients will be treated via VRO and iliac crest or
- bilateral sagital spilt osteotomy (BSSO) group (group II):- 10 patients will be treated via BSSO
- All patients will be studied by comprehensive clinical oral and maxillofacial examination and lateral cephalometric radiographic analyses, within 1 week before the surgery (T0), immediately after the surgery (T1), and 6 months after surgery (T2).
- All lateral cephalometric radiographs and clinical photographs must be standardized for all cases.
- After pre-surgical orthodontic treatment , a lateral cephalograph Will be obtained for planning the surgical movement of both jaws
- Surgical models and surgical stent will be fabricated.
- All surgical procedures will be performed under nasal intubation and general anesthesia to surgically reposition the maxilla in standard LeFort I setback fosteotomy; the BSSO group will be underwent BSSO, and VRO group will be underwent VRO
- The bony segments will be fixed in the new position with the use of custom made plates (specific for each patient )
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
- None
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
- •patients with age above 18 years old suffered from skeletal class II with severe mandibular deficiency
排除标准
- •patients with chin deviation,
- •severe temporomandibular joint (TMJ) symptoms.
- •Sever periodontal disease
- •pregnancy,
- •previous mandibular surgery,
- •inability to follow-up for the study protocol
研究组 & 干预措施
vertical ramus osteotomy with iliac graft group
Experimental
干预措施: vertical ramus osteotomy with iliac graft (Procedure)
Bilateral Sagittal Split Osteotomy Group
Active Comparator
干预措施: bilateral sagittal splitting osteotomy (Procedure)
结局指标
主要结局
skeletal stability
时间窗: 6 months
Skeletal stability will be assessed by lateral cephalometric x-ray. It will be done pre operatively, immediate postoperative, and 6 months later
次要结局
未报告次要终点
研究者
Shaimaa Mohsen
associate professor oral and maxillofacial surgery
Fayoum University
研究点 (1)
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