Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate in Two Groups One With IMMF and Anthor Without IMMF ;Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 主要终点
- stability of fracture segments.
研究概览
简要总结
comparative study evaluating stability of fracture segments in mandibular angle fracture with 3d strut plate with or with out post operative IMMF.
详细描述
Two group of patient with mandibular angle fracture indicated for open reduction and internal fixation ,first group will be fixed with 3d stut plate with post operative IMMF. Second group will be fixed with 3d strut plate with out post operative IMMF.
Eligble patients will be randomised in equal proportions between study group (3d strut plate with out post operative IMMF) and control group (3d strut plate with post operative IMMF).
A- 3D strut plate without post operative IMMF:
- Pre operative computed tomography will be done for patient.
- Intra operative :all cases will under go general anathesia.
- Exposure of the fracture segments using vestubular incision.
- Inter-maxillary fixation will be done.
- The fracture segment will be reduced in normal anatomic postion guided with occlusion.
- The fracture segment will be fixed in postion using 3d srut plate.
- Closure of surgical incision.
- Post operative computed tomograghy will be done for the patient.
- Patient will be dismissed from operation room without IMMF.
B- 3D strut with post operative IMMF:
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
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with mandibular angle fracture with or witout other fracture indicated for Open reduction internal fixation in the mandible.
- •Patient over 15 years old age and both sexes were included in this study.
- •Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- •Patients with good general condition allowing major surgical procedure under general anesthesia.
- •Patients with physical and psychological tolerance.
排除标准
- •Patients with comminuted fractures as it is not indicated for compression osteosynthesis like3d strut plate .
- •Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing.
- •Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.
研究组 & 干预措施
study group: 3d strut plate fixation without post op IMMF.
Open reduction and internal fixation with 3d strut plate without post operative IMMF.
干预措施: 3d strut plate. (Procedure)
control group: 3d srut plate fixation with post op IMMF.
Open reduction and internal fixation with 3d strut plate with post operative IMMF for 15 days.
干预措施: 3d strut plate. (Procedure)
结局指标
主要结局
stability of fracture segments.
时间窗: 15 days post operative.
post operative bimanual manipulation of the fracture segment.
次要结局
- inferior alveolar nerve injury.(pre operative and 1 week post operative.)
- Accuracy of fracture reduction.(one week post operative.)
研究者
Mohamed Khater tarek
Assistant lecturer.
Cairo University