Radiographic Assessment of Accuracy of Computer-assisted Polyether Ether Ketone (PEEK) Custom Made Plates Versus Computer-assisted Custom Made Titanium Plates in Treatment of Mandibular Body Fractures (A Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- radiographic assessment of accuracy in mandibular body fractures management
研究概览
简要总结
The design of the custom made Plates is customized to meet the individual needs of each patient and surgeon. By selecting plate design features, surgeons can customize the plate to create a patient specific solution. The Patient Specific Plates are manufactured to the planned patient anatomy, eliminating the time needed for intraoperative adaption and creating a stronger plate with a lower overall profile.
But Custom made plates were made in many materials such as titanium, Vitalium, PEEK, etc In this study we will compare the PEEK one with the titanium one to know which one is better in all aspects and if the PEEK one can overcome the shortcoming of the titanium one or not.
详细描述
In patients with mandibular body fractures, will PEEK custom made plates be more efficient in reduction of body fractures accurately than titanium custom made plates (in terms of radiographic and clinical parameters)?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with at least a unilateral body fracture indicated for Open reduction internal fixation.
- •-Dentate adult patients.
- •All ages and both sexes were included in this study.
排除标准
- •Patients with systemic disease (may affect normal healing).
- •Patients with old and/or mal united fractures (affect accuracy of re-reduced the fractured segments).
- •Patients whom cannot tolerate follow up intervals (affect accuracy of study results).
结局指标
主要结局
radiographic assessment of accuracy in mandibular body fractures management
时间窗: 3 months
using Mimics software
次要结局
未报告次要终点
研究者
Nahla Mahmoud Awad
associate professor of oral and maxillofacial surgery
Cairo University
