Clinical Assessment of Postoperative Occlusion in Patient With Mandibular Body Fractures Reduced and Fixed With Computer-assisted Polyether Ether Ketone (PEEK) Custom Made Plates Versus Conventional Titanium Plates (RCT)
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Postoperative occlusion
研究概览
简要总结
Two groups of patients with mandibular body fractures indicated for Open reduction internal fixation alone or in combination with fractures elsewhere in the mandible or midface. First group will be subjected to traditional titanium internal rigid fixation. Second group will be subjected to custom made PEEK plates.
详细描述
Two groups of patients with mandibular body fractures indicated for Open reduction internal fixation alone or in combination with fractures elsewhere in the mandible or midface. First group will be subjected to traditional titanium internal rigid fixation. Second group will be subjected to custom made PEEK plates.
Inclusion criteria:
All subjects were required:
- Patients with at least a unilateral body fracture indicated for Open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midface.
- All ages and both sexes were included in this study.
- Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- Patients with good general condition allowing major surgical procedure under general anesthesia.
- Patients with physical and psychological tolerance.
Exclusion criteria:
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
盲法说明
Because the two interventions used in this trial are clearly different and easily recognized by the participants and investigators, neither the investigator nor participants can be blinded
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with at least a unilateral body fracture indicated for Open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midface.
- •All ages and both sexes were included in this study.
- •Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- •Patients with good general condition allowing major surgical procedure under general anesthesia.
- •Patients with physical and psychological tolerance.
排除标准
- •Patients with physical and psychological intolerance. Because psychological stress will affect the immune system and general health.
- •Patients with systemic diseases like uncontrolled diabetes mellitus. Because uncontrolled diabetes mellitus has a negative impact on normal bone healing.
- •Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.
- •Patient with bad oral hygiene. As it has an influence on normal osseous healing
研究组 & 干预措施
Custom made PEEK plate fixation
Open Reduction Internal Fixation using Custom made PEEK plates.
干预措施: Custom made PEEK plate fixation (Procedure)
Titanium plate fixation
Open Reduction Internal Fixation using conventional titanium plating system.
干预措施: Titanium plate fixation (Procedure)
结局指标
主要结局
Postoperative occlusion
时间窗: 1 month postoperative
Restoration of normal patient occlusion will be assessed using Visual analog scale (VAS) (0-10)
次要结局
- Accuracy of the planned reduction(1st week)
- Wound dehiscence(1 month postoperative)
- The need for 2nd surgery(1 month postoperative)
- Operative time(During operation)
研究者
Rofaida Atef Atef
Assistant lecturer
Cairo University