Customized z Shaped Miniplate Versus Standard 2 Miniplates for Fixation of Parasymphyseal/Body Mandibular Fractures (a Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Presence of intra-fragmentary mobility
研究概览
简要总结
Mandibular fractures are a common type of facial fractures. The surgical treatment has developed over the years due to improved understanding of biomechanics, biomaterials and scientifically based treatment outcomes. since customized fixation mechanism is more suited to the bone surface which helps to meet the requirements of a semirigid fixation. Customized Z plate is a new geometry of miniplates that may provide superior preservation of mental nerve, stability, support and easier in adaptation compared to the standard 2 miniplates system for fixation of parasymhyseal/body mandibular fractures.
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 fractures at the parasymphysis/body of the mandible presented within 2 weeks of the date of trauma.
- •Radiographic evidence of parasymphyseal/body mandibular fracture that demands open reduction and internal fixation.
- •The patient is medically fit for general anesthesia
排除标准
- •comminuted fracture.
- •Pathological fracture.
- •Presence of infection
研究组 & 干预措施
Test Group "Customzied z Plate"
干预措施: customized Z shaped miniplate (Other)
Conventional treatment "Miniplates"
干预措施: conventional two miniplates (Other)
结局指标
主要结局
Presence of intra-fragmentary mobility
时间窗: up to 6 weeks
The mobility assessed by bi-manual palpation across the fracture site.
Change in bone density
时间窗: baseline and 6 months
Immediate CBCT scan will be used to assess the adequacy of fracture line reduction and fixation, and then another will be taken at 6th month to estimate the mean bone density at the fracture line in comparison with the immediate postoperative scan
Change in pain scores
时间窗: after 24-hours, one week, four weeks and six weeks
Patient asked to identify his pain sensation through a 10-point visual analogue scale (VAS) and the level of pain will be interpreted as (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).
次要结局
- Change in sensory nerve function(after 24-hours, one week, four weeks and six weeks)
研究者
Hams Hamed Abdelrahman
Lecturer of Dental Public Health and biostatistical consultanat
Alexandria University