Comparative Evaluation of 3D-printed Polyetheretherketone (PEEK) Plates Versus Titanium 3D Plate for Fracture Fixation at the Mandibular Angle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Postoperative occlusion stability(binary: yes/no)
研究概览
简要总结
Is patient specific customized computer assisted 3D PEEK plates more superior to 3D titanium plate in fixation of mandibular angle fractures?
详细描述
Open Reduction Internal fixation (ORIF) of mandibular angle fractures using titanium plating systems had several drawbacks including sepsis with subsequent wound dehiscence and the need for 2nd surgery which is attributed to bone loss as a result of the elevated modulus of elasticity of titanium hardware. Accordingly, attempts were made to overcome problems encountered with the titanium plating system. In this study, custom made PEEK 3D plates will be used in ORIF of mandibular angle fractures. The main beneficial property of PEEK material is its lower modulus of elasticity that is close to that of living bone with subsequent elimination of the problem of stress shielding phenomenon encountered with titanium plating system. PEEK material has other advantages including biocompatibility, mechanical strength, durability, resistance to high degree of temperature without dimensional alteration.
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
This study is an open-label randomized clinical trial. Due to the nature of the surgical intervention, blinding of participants and surgeons was not feasible.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mandibular angle fractures indicated for open reduction and internal fixation (ORIF).
- •Patients aged 18 years and above.
- •Both male and female patients.
- •Patients medically fit for surgery under general anesthesia.
- •Patients providing informed consent.
排除标准
- •Patients with pathological fractures.
- •Patients with comminuted fractures not suitable for fixation with plates.
- •Patients with systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
- •Patients with a history of previous mandibular surgery in the same region.
- •Patients who are unable or unwilling to comply with follow-up.
研究组 & 干预措施
Computer-assisted PEEK custom made 3D plates
Patients were treated using computer-assisted patient-specific PEEK plates manufactured by CAD/CAM technology and fixed using titanium screws.
干预措施: Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws. (Device)
3D titanium plates on the mandibular angle will be fixed using titanium screws
Patients were treated using conventional 3D titanium plates fixed with titanium screws after reduction of the fracture.
干预措施: Conventional 3D titanium plates (Device)
结局指标
主要结局
Postoperative occlusion stability(binary: yes/no)
时间窗: 1 week, 1 month, and 6 months postoperatively
Occlusal stability was recorded as stable or unstable. Occlusal stability was assessed clinically by evaluating the intercuspation between maxillary and mandibular teeth. Proper occlusion was defined as normal intercuspation without premature contacts or occlusal discrepancies. Any deviation, including open bite or malocclusion, was recorded during follow-up.
次要结局
- Condylar seating (binary: yes/no)(1 week, 1 month, and 6 months postoperatively)
- Postoperative infection (binary: yes/no)(1 week, 1 month, and 6 months postoperatively)
- Wound dehiscence (binary: yes/no)(1 week, 1 month, and 6 months postoperatively)
- Need for second surgical intervention ( binary: yes/no)(1 week, 1 month, and 6 months postoperatively)
研究者
Osama Abdelaziz Abdelreheem Abdelhaleem
Lecturer of Oral and Maxillofacial Surgery, Faculty of Dentistry
Cairo University