Twinfork miniplate versus Single miniplate for the fixation of fractures at parasymphysis - body Region of mandible - A Comparative study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Occlusion between the maxillary and mandibular teeth
研究概览
简要总结
Parasymphysis/body fractures of the mandible have reportedto occur with a frequency of 9% to 57%. Therefore, asurgeon should have an appropriate understanding of the biomechanics ofdifferent plating systems and techniques used to fix these fractures. There isalways a dilemma for the surgeon as to whether to fixthese mandibular segments with one or two miniplates, and the presence ofmental neurovascular bundle makes it more challenging.
The purpose ofthis study is to evaluate the biomechanicalbehavior of a newly designed twin-fork shaped miniplate for the fixation offractures involving the parasymphysis-body transition region and to compare thesame with the conventional single miniplates.
This randomisedcontrolled trial will be done on 30 patients requiring fixation of fractures in the parasymphysis- body transition zone of the mandible. In group A, fixation is done using twinfork miniplates and in group B, single miniplates are used for fixation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All fractures of mandibular parasymphysis-body(transition zone).
- •2.Patients in the age of 18- 65 yrs.
排除标准
- •1.Patients with fracture comminution.
- •2.Patients with frank infection.
结局指标
主要结局
Occlusion between the maxillary and mandibular teeth
时间窗: 1 month after surgery, 3 months after surgery
次要结局
- Bite force measured by placing a bite force instrument between maxillary and mandibular first molars(1 month after surgery, 3 months after surgery)