Comparison of Double Y-shaped Plates and Lag Screws in Fixation of Anterior Mandibular Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- progress of fracture healing in the postoperative period
研究概览
简要总结
This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, to compare Double Y-shaped plates and Lag Screws in fracture fixation from clinical and radiographic perspectives.
详细描述
This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, selected from those admitted to the Emergency Department of Alexandria University Hospital. Ethical approval for the study was obtained from the regional Ethical Review Board of the Faculty of Dentistry, Alexandria University. A written informed consent was signed by patients before the operation.
Patients were divided equally into two groups, each consisting of eight patients. Assignment of each patient into one of either group was done using computer random numbers.
Group 1: underwent open reduction and internal fixation using two lag screws. Group 2: underwent open reduction and internal fixation using double Y-shaped plates.
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 (Participant)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders
- •with age ranging from 25 to 45 years,
- •suffering from anterior fractures of the mandible (symphyseal or parasymphyseal)
排除标准
- •old fractures,
- •infected fractures
- •comminuted fractures
结局指标
主要结局
progress of fracture healing in the postoperative period
时间窗: after 6 months
Measurement of bone density in the fracture line using CBCT at 6 points and calculation of mean bone density
Sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side
时间窗: up to 6 months
Detection of nerve injury by examining sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side
次要结局
未报告次要终点
研究者
Lydia Nabil
Assistant Professor of Oral and Maxillofacial Surgery
University of Alexandria