Custom-Made 3D PEEK Plates Versus 3D Titanium Plates in Mandibular Angle Fracture Fixation: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Radiographic evaluation for the assessment of mean bone density at the fracture line [Time Frame: 12 weeks]
研究概览
简要总结
This investigation aimed to determine the clinical and radiographic efficacy of patient-specific, custom-made 3D PEEK plates in comparison with 3D titanium plates for the management of mandibular angle fractures.
详细描述
Eighteen patients with recent mandibular angle fractures indicated for open reduction and internal fixation were randomly allocated into two groups. The study group (n = 9) underwent fixation with custom-made 3D PEEK plates, while the control group (n = 9) received prebent 3D titanium plates adapted on virtually reduced models. Follow-up extended to 12 weeks. Clinical parameters included operative time, postoperative occlusion, interfragmentary stability, wound healing, and bite force recovery. Radiographic evaluation was conducted using computed tomography scans acquired immediately postoperatively and at 12 weeks, assessing fracture healing and mean bone density.
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
- Single (Investigator)
盲法说明
Patients were allocated in a 1:1 ratio using an on-site computer software system with concealed allocation through sequentially numbered, opaque, sealed envelopes (SNOSE). Group A was treated with custom made 3D PEEK plates and Group B with 3D titanium plates.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with recent mandibular angle fracture adults without gender predilection who agreed to follow-up, fractures requiring open reduction and internal fixation, medically fit for general anesthesia
排除标准
- •medically compromised patients, fractures with infection, pathological or old fractures, completely edentulous patients, comminuted fractures
研究组 & 干预措施
patients with recent mandibular angle fractures managed with custome made 3D PEEK plate
custome made 3D PEEK plate
干预措施: Custome made 3D PEEK plate (Device)
patients with recent mandibular angle fractures managed with 3D Titanium plates
3D Titanium plates
干预措施: 3D Titanium plate (Device)
结局指标
主要结局
Radiographic evaluation for the assessment of mean bone density at the fracture line [Time Frame: 12 weeks]
时间窗: 12 weeks
Mean bone density at the fracture line was assessed using Computed Tomography (CT) scan in Hounsfield Units (HU)
Bite force recovery.
时间窗: 12 weeks
bite force recovery measured by a Piezoresistive force transduce sensor: FlexiForce A201 sensor (FlexiForce sensor, by Tekscan Boston, MA, USA. www.tekscan.com)
次要结局
- Clinical evaluation for interfragmentary stability.(12 weeks)
- clinical evaluation of wound healing(14 days)
- Clinical evaluation of postoperative occlusion(12 week)