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临床试验/NCT07403708
NCT07403708已完成不适用

Retromandibular Transparotid Approach Versus Transmasseteric Anteroparotid Approach for Fixation of Subcondylar Fracture: Randomized Controlled Clinical Study

Alexandria University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
facial nerve injury

研究概览

简要总结

Background: Condylar fracture is one of mandibular fracture which accounts for 20-35%. It is the most controversial fractures regarding diagnosis and management. For several years, surgeons preferred closed reduction over open reduction to avoid surgical complications.

Closed reduction may have late complications, the preference started to change towards open treatment. A Transmasseteric Anteroparotid (TMAP) approach for open treatment of condylar fractures overcomes the problems of facial nerve injury of other approaches. Aim: Comparing the Transmasseteric Antroparotid approach(TMAP) to the Transparotid (TP) approach in management of subcondylar fractures regarding the facial nerve affection, parotid fistula, reduction angulation, pain, duration of the surgery, occlusion and patient satisfaction with the scar. Materials and Methods: Twenty patients with subcondylar fracture will be divided randomly into two equal groups. Group1(study group): Transmasseteric Antroparotid approach. Group2 (control group): Retromandibular Transparotid approach. Patients will be followed up for 3 months to assess facial nerve injury, pain, occlusion and patient's scar satisfaction . Results: data will be collected, tabulated and statistically analysed.

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
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suffering from displaced extracapsular mandibular subcondylar fracture indicated for open reduction including:
  • Difficulty of obtaining adequate occlusion by closed method. Radiological signs of the following:
  • Deviation of the he fragments from the axis of the ascending ramus in medial or lateral direction more than 10°. (28)
  • Shortening of the ascending ramus ≥ 2 mm measured from the roof of glenoid fossa to the inferior border of the ascending ramus of the mandible.
  • Dislocation of the condyle from the glenoid fossa.

排除标准

  • Patients who were not able to follow the information given or to make a decision themselves due to mental or other problems.
  • Patient with undisplaced condylar fractures that doesn't cause malocclusion or loss of facial heightening and can be treated conservatively.

研究组 & 干预措施

transmasseteric anteroparotid approach

Experimental

干预措施: transmasseteric anteroparotid approach (Procedure)

transparotid approach

Active Comparator

干预措施: transparotid approach (Procedure)

结局指标

主要结局

facial nerve injury

时间窗: immediate postoperative

次要结局

  • approach time(interaoperative)

研究者

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

mona oraby

Dr.

Alexandria University

研究点 (1)

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