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临床试验/NCT03803150
NCT03803150已完成不适用

A Comparative Study Between Preauricular Retromandibular Anteroparotid Approach and Retromandibular Transparotid Approach in Internal Fixation of Subcondylar Fracture on Facial Nerve Injury and Parotid Fistula

Cairo University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Minimize facial nerve injury

研究概览

简要总结

Of all the bones in the maxillofacial area, the condylar process is the most susceptible to fracture. The incidence of condylar fracture accounts for 25% to 50% of all mandibular fractures. Though remained controversial for a long time, surgical treatment of displaced subcondylar fractures appears today as the gold standard.

Although there is a developing preference for open reduction and internal fixation of mandibular condylar fractures, the optimal approach to the ramus condylar unit remains controversial. Various approaches have been proposed, and each has specific shortcomings and disadvantages. Retromandibular, submandibular, transoral, and through parotid approaches are generally performed and sometimes used with an endoscope. Limited access and injury to the facial nerve are the most common problems, while Wilson introduced a new through masseter anteroparotid approach, this technique offers excellent access to the ramus condylar unit, and facial nerve damage risk is reduced.

详细描述

Fractures of the mandibular condylar process have been documented to be one of the most common occurring mandibular fractures.

When open treatment is selected, several surgical approaches can be used to expose, reduce, and stabilize the fracture site, each with its own set of advantages and disadvantages. Surgical approaches to the fractured mandibular condyle are broadly classified into intraoral and extraoral approaches. Intraoral approaches can be performed with or without endoscopic assistance. The most common extraoral approaches are submandibular, Risdon, preauricular, retroauricular, and retromandibular through parotid or through masseter approaches.

An intraoral approach is time consuming and requires special instruments such as an endoscope, and additional training. Furthermore, cases of high fractures and/or medially displaced condylar fractures are technically difficult to manage through an intraoral approach, incorrect anatomical reduction, condylar head resorption, myofascial pain, and malocclusions have been reported to be more common complications following the intraoral approach when compared to extraoral approaches.

In contrast, extraoral approaches are commonly used because they produce better visualization of the fracture site and therefore facilitate fracture reduction and fixation. However, extraoral approaches are complicated by the risk of injury to the facial, great auricular, and auriculotemporal nerves, visible scars, sialoceles, Frey syndrome and salivary fistulas.

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
None

盲法说明

Senior supervisor Prof. Dr. Hairy El mossy will generate the allocation sequence.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age should be more than 18 year.
  • Patients with subcondylar fracture and need to open reduction and internal fixation using titanium miniplates.
  • Patients should be free from any traumatic injuries to facial nerve or parotid gland.
  • Availability of preoperative and postoperative panoramic radiographs and/or computed tomography (CT) images.
  • Mental status permitting an adequate neuromotor examination.
  • Regular clinical follow-up, documented in our clinical and radiographic evaluation charts, at 1 week, 1 month, 3 months and 6 months postoperatively

排除标准

  • Intraoral treatment of subcondylar fracture.
  • Incooperative patients.

结局指标

主要结局

Minimize facial nerve injury

时间窗: Concerning the facial injury will be at 6 months

Regarding facial nerve injury the measuring device is House- brachmann facial nerve grading system (HBFNGS) while the measuring unit is numerical from (I-VI) I= Normal, II= Mild dysfunction, III= Moderate dysfunction, IV= Moderately severe dysfunction, V= Severe dysfunction, VI= Total paralysis. I= Better while VI= Worse

Minimize salivary fistula

时间窗: Salivary fistula at 1 week

Regarding salivary fistula the measuring device is clinical examination while the measuring unit is binary question.

次要结局

  • Reduce scar formation(at 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hani Taher Hibatullah Ali

Principle Investigator

Cairo University

研究点 (2)

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