Comparison of Open Reduction With Internal Fixation and Closed Reduction With External Fixation of Mandibular Sub-Condylar Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- Mouth Opening
研究概览
简要总结
Patients with mandibular sub-condylar fractures underwent either either open reduction with internal fixation (ORIF) or closed reduction with external fixation (CREF) and were followed up for 6 months to assess treatment adequacy with the hypothesis that ORIF is superior to CREF.
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
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16-60 years
- •Displaced Mandibular Subcondylar Fractures(MCFs) irrespective of multiple mandibular fractures.
排除标准
- •Bilateral MCFs
- •MCF with mid-facial fractures
- •Insufficient bilateral dentition
- •Medically unfit for surgery
- •Old healed mandibular fractures
- •History of previous mandibular surgery for the same indication
研究组 & 干预措施
ORIF
Open Reduction & Internal Fixation
干预措施: Open Reduction & Internal Fixation (Procedure)
CREF
Closed Reduction & External Fixation
干预措施: Closed Reduction & External Fixation (Procedure)
结局指标
主要结局
Mouth Opening
时间窗: 6 months
Mouth Opening shall be determined by measuring the maximal distance between the edges of upper and lower incisors with fully opened mouth; the measurement shall be made in millimeters (mm) using vernier caliper and mouth opening of 35 mm or more shall be classified as "adequate"
Occlusion
时间窗: 6 months
Occlusion shall be determined by maximum "inter-cuspation" as observed by the surgeon and patient self-reporting and will be classified as fine or deranged.
次要结局
- Complications(6 months)
- Cost-Effectiveness(6 months)
- Patient Satisfaction(6 months)
研究者
Samira S Baloch
Assistant Professor of Oral & Maxillofacial Surgery
King Edward Medical University