Evaluation of the Accuracy of Patient Specific Implant in Fixation of Mandibular Sagittal Split Osteotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Accuracy of PSI and bony segment movements
研究概览
简要总结
Study was Conducted on Patients were need BSSO Using PSI for reposition and fixation
详细描述
A prospective study was conducted, and it included 8 patients. All patients underwent mandibular sagittal split osteotomy (BSSO) using PSI for repositioning and fixation. All patients were followed up clinically for immediate,1,3,6 weeks, and 3 months postoperatively after the surgical operation to assess the occlusion, presence of numbness, bleeding, and possible temporomandibular joint (TMJ) changes. All patients underwent immediate and 3 months Ortho pantomogram, postoperative CT were superimposed to the planned preoperative CT scan to evaluate the accuracy of PSI in fixation and merging of Digital dental model to the postoperative CT scan.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range of patients 18-40 years old, with no gender prediction, able to read and sign the informed consent.
- •Patients with skeletal class II or class III who are in need of mandibular orthognathic surgery.
排除标准
- •Patients who had previous orthognathic surgery.
- •Patients with previous severe facial trauma history or fracture mandible.
- •Patients with congenital facial asymmetry.
- •Patients with systemic diseases and immunocompromised patient.
结局指标
主要结局
Accuracy of PSI and bony segment movements
时间窗: Baseline (preoperative), immediate postoperative, and 3-month postoperative follow-up.
Measurements using CT software after superimposition using (Mimics and 3-Matic) through fixation landmark points on both virtually planned repositioned mandible and the actual postoperative mandible, all in identical locations. Then linear measurements were performed between defined anatomical landmarks on both models using Measure distance tool, as well as between each landmark and the constructed reference planes
次要结局
未报告次要终点
研究者
Eman Ashour
Assistant Lecturer at Oral and Maxillofacial Surgery department at AlAzhar University
Faculty of Dental Medicine for Girls