Precision of Patient-specific Screw Holes Locating Surgical Guide and Pre-bent Plates Osteosynthesis Versus Classical Workflow in the Management of Class IV Mandibular Fractures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Accuracy of fracture reduction
研究概览
简要总结
This study aims to overcome the limitations of current, standard approach of mandibular fracture reduction and fixation including improper alignment of segments, malocclusion, nerve affections and related teeth roots injury. The introduction of Computer Aided designing/Computer Aided manufacturing software has provided surgeons with an opportunity to perform virtual manipulations of computed tomography datasets preoperatively and production of corrected mandibular model for plate pre-bending and fabrication of plate locating surgical guide which provide accurate segment reduction and fixation with accurate post-operative occlusion and minimal post-operative complication.
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)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with delayed mandibular class IV fracture need open reduction and internal fixation.
- •Patients with a medical history that did not hinder plate placement (uncontrolled diabetes) and adequate proper oral hygiene.
- •Both genders, males and females, will be included
排除标准
- •General contraindications to surgery.
- •Patients with unfavorable or comminuted fractures.
- •Subjected to irradiation in the head and neck area less than 1 year before fixation.
- •Poor oral hygiene and motivation.
- •Uncontrolled diabetes.
- •Pregnant or nursing.
- •Substance abuse.
- •Psychiatric problems or unrealistic expectations.
- •Severe bruxism or clenching.
- •Immunosuppressed or immunocompromised.
- •Treated or under treatment with intravenous amino-bisphosphonates.
- •Patients participating in other studies, if the present protocol could not be properly followed.
研究组 & 干预措施
patient-specific screw holes locating surgical guide and pre-bent plates osteosynthesis
Patients In this group will be reduced using patient computer-guided specific screw holes locating guide and pre-bent plates(2.3 for inferior border and 2.0 for superior border)
干预措施: patient-specific screw holes locating surgical guide and pre-bent plates (Device)
classical work-flow
Patients In this group will be reduced by classical reduction and fixation protocol
干预措施: 2 titanium per-bent mini plates (Device)
结局指标
主要结局
Accuracy of fracture reduction
时间窗: Within one week postoperatively
Accuracy of fracture reduction, measured as the mean linear deviation (in millimeters) between the postoperative Computed Tomography scan and the preoperative virtual surgical plan Method of assessment: Postoperative Computed Tomography scans will be superimposed onto the preoperative virtual plan using 3D analysis software (e.g., Mimics/3-matic or equivalent). Linear and angular deviations of fracture segments will be calculated at predefined anatomical landmarks.
次要结局
- Occlusion(At 1 week, 1 month, 3 months, and 6 months postoperatively)
- Operation time(During the surgery)
研究者
Mohamed abdelsalam Gaber elkhouly
Resident oral and maxillo-facial surgery
Cairo University