Assessment of Condylar Position With Management of Unilateral Mandibular Angle Fracture
Assessment of Condylar Position With Management of Unilateral Mandibular Angle Fracture Using Patient Specific Angle Plate Versus Two Mini Plates (Randomized Clinical Trial)
The objective of this study is to assess condylar position and occlusion after open reduction and internal fixation using two miniplates versus patient specific plate
研究概览
详细说明
Accordingly, this trial will be held using self-positioning specific plate to overcome such problems of the two-point fixation of mini plates : 1. The virtual planning and with aid of plate wings minimize the need for intra-operative IMF during fixation stage.
2.The virtual planning and fabrication of self-seating wings (lips) of the patient-specific plate ensure the seating of the condyle and centric relation.
Finally, the PSP will make fracture the reduction more accurate and will offer a great advantage of reduction of the operative time .
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Giza、埃及、12613
- oral and dental medicine Cairo university
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria
1. Patients with a unilateral angle fracture indicated for Open reduction internal Fixation alone or in combination with fracture elsewhere in the mandible.
3. Patients should be free from any systemic disease that may affect normal healing of the bone.
4. Patients with good general condition allowing major surgical procedure under general anesthesia.
5. Patients with physical and psychological tolerance No history of previous surgical intervention in the angle site
Exclusion criteria :
- 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.
- Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：patients treated by two mini plates
patient fixed by 2 mini plates |
patients with mandibular angle fractures fixed by 2 mini plates |
|
实验性的：fixation with patient specific plate
the Patient specific plate will make fracture the reduction more accurate and will offer a great advantage of reduction of the operative time |
Angle fracture will be fixed by patient specific plates customized for him |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Assessment of condylar position (Linear displacement)
大体时间：3 months
|
Linear displacement (inter condylar distance) with computed tomography in millimeters |
3 months
|
|
Assessment of condylar position (Angular displacement)
大体时间：3 months
|
Angular displacement with specialized software in degrees |
3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
assessment of occlusion
大体时间：3 months
|
Assessed by clinical photographs (Binary) |
3 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- omfs3-3-19
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