Radiographic and Clinical Evaluation of Three-Dimensional Delta Plate in Internal Fixation of Mandibular Sub-condylar Fractures.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- posterior vertical height and anatomic reduction using CT
研究概览
简要总结
In this study, we intend to examine the efficacy of 3D delta plates through radiographic evaluation of anatomic reduction and vertical ramus height as the main outcome and clinical assessment of pain and range of mandibular movements as secondary outcomes.
This Single arm longtudinal study will include 14 cases of trauma having mandibular sub condylar fractures, in which open reduction and internal fixation are indicated.
After selecting patients according to the inclusion criteria, all patients will undergo open reduction and rigid fixation.
Fracture will be stabilized using 4 hole, 2.0 mm 3-D Delta titanium plates using pre-auricular or retromandibular incision.
Radiographic evaluation using Computed Topograhy (CT) scans will be carried on immediatly after the operation then 3 months post operatively.
While, Clinical assessment will be performed at the following intervals after the surgery( 1 week, 1 month, 3 months)
详细描述
The study was conducted on fourteen patients suffering from unilateral mandibular subcondylar fractures gathered from Ain Shams University Department of Oral and Maxillofacial Surgery, Ahmed Maher Teaching Hospital and El-Bank El-Ahly Hospital for Integrated Care.
The used 3D plate is made of titanium, it is 1 mm thick, 20 mm long with a base measuring 14 mm and an apex measuring 5 mm. It has 4 holes (2 at the base and 2 at the top), where 2,00 mm screws can fit in.
The aim of this study is to evaluate the versatility of the three-dimensional delta plate in reduction and fixation of unilateral sub-condylar fractures. The results will be analyzed by radiographic assessment of proper anatomical reduction and measurement of vertical ramus height. In addition to, clinical outcomes of pain with jaw movements and measurement of all mandibular movements range.
Criteria of patients' selection :
Inclusion Criteria:
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
- 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 at or over 18 years.
- •Unilateral sub condylar fractures. -
排除标准
- •Bilateral sub condylar fractures
- •Pediatric patients.
- •Intracapsular fractures
- •Patients with Uncontrolled systematic conditions. -
结局指标
主要结局
posterior vertical height and anatomic reduction using CT
时间窗: 3 months
Radiographic evaluation of posterior vertical height and anatomic reduction using CT
次要结局
未报告次要终点