Evaluation of Accuracy of the Use of 3d Printed Reduction Guide in Treatment of Mandibular Fractures Using Two Different Methods of Virtual Planning
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Evaluation of accuracy of mandibular reduction of each surgical guide.
研究概览
简要总结
This study will evaluate the accuracy of the use of 3-D printed reduction guide in treatment of mandibular fractures using two different methods of virtual planning.
详细描述
This study will be conducted clinically on 24 patients with mandibular fracture divided into 2 groups, (group A) virtual planning will be done using the manual virtual reduction method and (group B) virtual planning will be done using the mirror image technique. Design of the reduction guide will be done in accordance with the virtual plan. The surgical reduction will be done with the aid of the guide.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients were allocated in a 1:1 ratio using an on-site computer software system with concealed allocation through sequentially numbered, opaque, sealed envelopes (SNOSE). (group A) virtual planning will be done using the manual virtual reduction method and (group B) virtual planning will be done using the mirror image technique.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically fit patients free from relevant conditions contraindicating surgery.
- •Unilateral mandibular fractures indicated for open reduction and internal fixation
排除标准
- •Infected fracture site.
- •Patients with systemic bone diseases.
研究组 & 干预措施
virtual planning will be done using the manual virtual reduction method
virtual planning will be done using the manual virtual reduction method and . Design of the reduction guide will be done in accordance with the virtual plan. The surgical reduction will be done with the aid of the guide.
干预措施: Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the manual reduction technique. (Device)
virtual planning will be done using the mirror image technique.
virtual planning will be done using the mirror image technique. Design of the reduction guide will be done in accordance with the virtual plan. The surgical reduction will be done with the aid of the guide.
干预措施: Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the mirror image reduction technique. (Device)
结局指标
主要结局
Evaluation of accuracy of mandibular reduction of each surgical guide.
时间窗: Immediately after the surgery
Evaluation of accuracy of surgical guide will be done using slicer and blender software with the aid of the preoperative and postoperative CT. Preoperative planning will be merged with the new CT data to identify the accuracy of reduction. Landmark-Based Positional Analysis was used to quantify positional accuracy of the reduced mandibular segment. Bilateral mandibular landmarks were selected to represent the spatial position of the fractured and adjacent segments. The selected landmarks included condylion (Co), gonion (Go), and mental foramen (MF), which are distributed across the mandibular ramus, angle, and body regions. linear distances to the three reference planes were recorded in millimeters. To provide a comprehensive three-dimensional representation of positional discrepancy, an asymmetry index (AI) was calculated for each bilateral landmark.
次要结局
- Clinical evaluation of postoperative occlusion(3 months)