Evaluating the Efficacy of Patient Specific Z-shape Mini-plate With Lingual Extension Versus Usual Two Mini-plates in Mandibular Class III Fracture Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- inter condylar distance
研究概览
简要总结
The collected patients according to the eligibility criteria will be randomly distributed into one of these groups:
Group I : 10 patients suffering class III mandibular fracture will be managed by patient specific Z shape mini-plate with lingual extension (study group).
Group II : 10 patients suffering class III mandibular fracture will be managed by 2 mini plates at superior and inferior borders (control group).
The allocation sequence will be generated using computerized random numbers and kept in sealed envelopes, which will be opened prior to surgery. All patients will provide the informed consent after declaration the procedures, benefits, and harms
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Class III mandibular fracture
- •medically stable patient
- •aged above 21 years
- •no medical condition affect the bone healing
排除标准
- •• absence of other facial trauma, mandibular condylar fracture
- •patient refuse the follow up
结局指标
主要结局
inter condylar distance
时间窗: 3 months
次要结局
未报告次要终点
研究者
Shaimaa Mohsen
associate professor
Fayoum University