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临床试验/NCT03761524
NCT03761524Unknown不适用

Evaluation of the Effect of Customized V Plate Fixation Versus a Conventional Superior -Inferior Miniplates Fixation of Mandibular Angle Fracture on Mouth Opening and Radiographical Parameters Randomized Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
24
试验地点
2
主要终点
Mouth Opening

研究概览

简要总结

The aim of the study to evaluate the effect of customized V pattern plate fixation versus a conventional superior-inferior mini plates fixation of mandibular angle fracture on mouth opening and radio graphical parameters.

详细描述

The mandibular angle is one of the most common sites for fractures, accounting for 23-42% of all cases of mandibular fractures. Moreover, mandibular angle fractures have the highest postoperative complications among all mandibular fractures, and the loosening of screws and fracturing of plates are main reasons for the complications.The most widely used treatment modality for mandibular angle fracture is the use of one miniplate fixation ,The other one uses two mini-plates, with a upper mini-plate fixed at the same place of previous treatment which corresponds to the tension band of the mandible, and the lower mini-plate fixed at the inferior border of the mandible which corresponds to the compression band of the mandible, however, based on recent experimental and clinical studies, the stability provided by the miniplate fixation of mandibular angle fractures has become a point of contention among surgeons .In order to decrease the need for plate removal, reduce the operative time and improve the stability of the fixation system, a customized V pattern plate design is an appropriate plate structure for fractured mandible using the minimum output values for stress of plate and displacement of bony segments to seek maximum reduction volume on an original plate .Patient satisfaction include: clinical parameters such are occlusion, pain, facial swelling, maximal mouth opening, sensory function, and surgical wound ,these should be evaluated postoperatively ,radio graphical evaluation is also an important parameter to assess adequate reduction of the fractured segments .

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 (Outcomes Assessor)

盲法说明

Because the two interventions used in this trial are easily recognized by the participants and the investigator, neither the investigator nor the participant can be blinded. But, assessor and the statistician will be blinded.

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with at least a unilateral unfavorable angle fracture indicated for Open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midrace.
  • Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome

排除标准

  • Patients with systemic disease (may affect normal healing).
  • Patients with old and/or malunited fractures (affect accuracy of reduction of the fractured segments).
  • Patients whom cannot tolerate follow up intervals (affect accuracy of study results).

研究组 & 干预措施

Customized V plate fixation

Experimental

Computed tomography (CT) scan of the Facial bones (Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1mm )is taken for the patients and a customized V pattern plate

干预措施: Customized V plate fixation (Procedure)

Conventional miniplates fixation

Active Comparator

Conventional superior-inferior miniplates fixation of mandibular angle fixation

干预措施: Conventional miniplates fixation (Procedure)

结局指标

主要结局

Mouth Opening

时间窗: Every week for 1 month ,3 months and 6 months postoperative

Mouth Opening is evaluated by measurement of maximal interincisal opening between maxilaary and mandibular central incisiors by the caliper and measuring unit is mm

Radiographical parameters

时间窗: At 3 and 6 months postoperatively

Radiographical parameters (Bone Density) is detected through CT scan to evaluate bone density in Hounsfield unit in the area of plate fixation to determine the effect of the plate stress over the fracture site Measures format will be summarized as mean

次要结局

  • Occlusion(immediate postoperative day)

研究者

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

Hiba Obad Saleh Saeed

Principle Investigator

Cairo University

研究点 (2)

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