Mandibular Sub-condylar Fractures Fixation Using Three-dimensional Custom Plate Versus Standard Titanium Fixation Plates: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Bite force
研究概览
简要总结
This randomized clinical trial aims to conduct a comprehensive clinical and radiographic evaluation by comparing the efficacy of standard titanium fixation plates with three dimensional custom plate in the management of sub-condylar fractures. By assessing the clinical outcomes, accuracy of reduction of the fracture segments, and bite force promoted by both fixation modalities.
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 (Outcomes Assessor)
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
- •Displaced sub condylar fractures, requiring open reduction and rigid internal fixation
- •Age ranges from 18 to 60 years
- •Fracture duration less than 2 weeks
- •Patients with adequate follow up duration for outcome assessment
排除标准
- •Comminuted sub condylar fractures
- •Patients with severe systemic diseases that may affect fracture healing
- •Presence of any pathology at the fracture site
- •Patients with previous history of mandibular surgery
- •Medically compromised patients who are not fit to undergo surgery under general anesthesia
- •Patients with in complete medical records or missing follow up data
研究组 & 干预措施
3D Custom Plate group
Patients in this group will undergo open reduction and internal fixation of displaced mandibular sub-condylar fractures using preoperatively designed and 3D-printed patient-specific titanium plates.
干预措施: 3D custom plate (Device)
Standard titanium plates group
Patients in this group will undergo open reduction and internal fixation of displaced mandibular sub-condylar fractures using the conventional technique, involving either two standard titanium miniplates or a single 2.3 mm titanium plate.
干预措施: Standard titanium fixation plates (Device)
结局指标
主要结局
Bite force
时间窗: 1 month, 3 months, and 6 months postoperatively
Bite force measured in Newtons at the molar region using a bite force recording device.
次要结局
- Maximum mouth opening(1 month, 3 months, and 6 months postoperatively.)
- Mandibular deviation on opening(1 month, 3 months, and 6 months postoperatively.)
- Accuracy of fracture reduction(Immediately postoperative (within 1 week))
研究者
Esraa Mosad Tawfik
Resident, Oral and Maxillofacial Surgery
Cairo University