Validity of Safety-zone Approach on Facial Nerve Preservation During Transbuccal-accessed Fixation of Mandibular Fractures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Postoperative Facial Nerve Affection Using Sunnybrook Facial Grading System (in numbers from 0 to 100)
研究概览
简要总结
The goal of this study is to investigate the efficacy of a safety-zone that is anatomically landmarked on the face of patients with mandibular fractures that are approached transbuccally (through cheek) on postoperative intactness of facial nerve.
详细描述
Mandibular fractures, in particular mandibular angle fractures, can be fixed with various techniques. Of all, open reduction and internal fixation (with titanium plates and screws) stands as one of the most commonly used techniques for mandibular angle fracture management.
Different approaches could be followed to access the mandibular angle. Transbuccal approach is considered one of the most conservative approaches for such goal. Conjoined with a transoral access for fracture reduction and plates adaptation, a small incision is made extraorally on the cheek opposite to the fracture line to facilitate application of a transbuccal trocar, through which drilling and screws fixation can be done into the plates.
A reported risk of facial nerve injury raises fears towards this extraoral cheek incision, even being considerably small. That's why a safety-zone was proposed as a triangle between three lines drawn cross each other. The first is drawn from the ear tragus to the facial notch. The second is drawn from the outer eye canthus to the mandibular angle. The third is on the lower mandibular border. This safety-zone triangle was suggested beforehand in a cadeveric study to be a safe land for cheek incisions without endangering the facial nerve branches, in particular buccal and marginal mandibular branches.
This study aims at testing whether the implementation of this safety-zone may decrease the risk of facial nerve affection among patients in whom these landmarks were followed, or there may not be such difference between these patients and other patients who underwent same fracture pattern management with the same approach but without implementing these safety-zone landmarks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients (American Society of Anesthesiologists Class I)
- •Patients with mandibular fracture that require open reduction and internal fixation with miniplates and screws.
- •Mandibular fractures that couldn't be accessed transorally only.
- •Non-comminuted fractures
排除标准
- •Patients with neurological disorders.
- •Patients who take nerve-supporting supplements (such as Vitamin B12 or Vitamin B complex) prior to surgery.
- •Presence of facial laceration.
- •Infected fractures
研究组 & 干预措施
Control Group (No Safety-Zone)
Patients with mandibular angle fractures undergoing open reduction and internal fixation (ORIF) will be approached transbuccally without landmarking extraoral safety-zone for cheek incision
Study Group (Safety-Zone)
Patients with mandibular angle fractures undergoing open reduction and internal fixation (ORIF) will be approached transbuccally after landmarking extraoral safety-zone for cheek incision
干预措施: Landmarking Safety-zone (Procedure)
结局指标
主要结局
Postoperative Facial Nerve Affection Using Sunnybrook Facial Grading System (in numbers from 0 to 100)
时间窗: First postoperative week, and third postoperative week.
Facial nerve function is tested after surgery through subjective facial expressions by the patient and judged by two different investigators grading them on Sunnybrook Facial Grading System
次要结局
未报告次要终点
