Precision of Patient Specific Screw Holes Locating Surgical Guide and Pre-bent Plates Osteosynthesis Versus Classical Work-flow in Management of Class III Mandibular Fractures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 主要终点
- computer tomography
研究概览
简要总结
The aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the classical work flow
详细描述
Research question:
Does the use of screw holes locating surgical guide & pre-bent plates osteosynthesis accurately reduce class III mandibular fractures regarding segments integrity and occlusion more than the classical reduction and fixation?
Statement of the problem:
Mandibular fractures are the most frequently occurring fractures within the maxillofacial injuries. The evaluation, diagnosis, and management of these fractures remain challenging despite improved imaging technology and fixation techniques. Depending on the type and location of the fractures, various open and closed surgical reduction techniques can be utilized. There are several critical and inherent limitations to the current ,standard approach of mandibular fracture reduction and fixation includes : (improper alignment of segments ,malocclusion ,nerve affections and related teeth roots injury).
There is a possibility to overcome these limitations with the help of computer-guided surgery . The introduction of CAD/CAM software has provided surgeons with an opportunity to perform virtual manipulations of CT 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 . The aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the conventional work flow
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with delayed and isolated mandibular class III fracture needs open reduction and internal fixation.
- •Patients with 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 fresh fractures (mobile segments).
- •Patients with unfavourable nor comminuted fractures.
- •Subjected to irradiation in the head and neck area less than 1 year before fixation.
- •Untreated periodontitis.
- •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.
结局指标
主要结局
computer tomography
时间窗: after 3 months
the Computer Tomography Will calculate the segments deviation in mm. after 3 month .
次要结局
未报告次要终点
研究者
Abdallah Gaber Ali Mohamed
Researcher
Cairo University
