New Design Sagittal Split Plate Versus Two Miniplates in the Treatment of Mandibular Angle Fractures (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in pain scores
研究概览
简要总结
Mandibular fractures are the second most common maxillofacial fracture after nasal bone fracture. As a result, a lot of research work has gone into improving treatment methods for these fractures including, reduction of immobilization period and enhancement of rigid fixation. One of these modalities is the use of Sagittal Split plate at the angle of the mandible.
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from recent, uninfected angle mandibular fracture.
- •Fracture that demands open reduction and internal fixation.
排除标准
- •Medically compromised patients contradicting the operation.
- •Existence of infection at the fracture line.
- •Pathological fracture.
- •An old fracture.
研究组 & 干预措施
Conventional Group
干预措施: two conventional miniplates (Procedure)
Test Group
干预措施: single Sagittal Split plate (Procedure)
结局指标
主要结局
Change in pain scores
时间窗: baseline, 24 hours, 1 week, and 6 weeks
Will be assessed through a 10-point Visual Analogue Scale (VAS) (34). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).
Change in Maximal Inter-Incisal Mouth
时间窗: baseline, 24 hours, 1 week, and 6 weeks
Using a millimeter ruler to measure maximal inter-incisal mouth opening
次要结局
- postoperative infection(24 hours, 1 week, and 6 weeks)
- change in bone density(baseline and 12 weeks)