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临床试验/CTRI/2022/09/045454
CTRI/2022/09/045454已完成4 期

Comparative Evaluation of Clinical and Radiological Outcomes of Open Reduction & Internal Fixation of Unilateral Subcondylar Fracture With and Without Use of Virtual Surgical Planning and Surgical Template –A Randomised Clinical Study

MGM Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年9月14日最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
16
试验地点
1
主要终点
To evaluate and compare the clinical outcomes such as

研究概览

简要总结

Mandibular Condylar fractures are relatively common accounting for 29% to 52% of all Mandibular fractures. There are various classification systems describing Mandibular Condylar fractures based on the anatomical position of fracture, degree of displacement and/ or dislocation. There are two principal treatment modalities for these fractures. Traditionally conservative management was most preferred but in recent years Open reduction & Internal fixation (ORIF) has become the method of choice because it can provide better functional and morphological outcomes in terms of mouth opening, occlusal status and facilitates anatomic reduction of Condyle. The challenges most often faced during ORIF include difficulty in controlling the small proximal fragment and achieving good stability. The struggle to achieve good reduction and fixation often prolongs the intraoperative time. Advent of Computed tomography and 3D modelling have enabled better understanding of the level of fracture, degree of comminution, obliquity along the fracture line and hence better treatment planning. Virtual surgical planning has been recently introduced which has enabled surgeons to perform the repositioning of the fragment virtually andpresumably select and precontour the appropriate fixation device thus reducing the intraoperative time and increasing the accuracy of reduction and fixation. This idea has been adopted following its proven efficacy in treatment planning in reconstructive surgeries with Bone grafting and free tissue transfers. A surgical template can made with the help of virtual surgical planning which can aid in holding the proximal fragment in position and help in precise reduction, better control of the proximal fragment and ensure placement of plates in the preplanned position and overall reduce the intraoperative time.The aim of the study is to evaluate whether the use of virtual surgical planning and surgical template can provide an anatomic reduction, require less intraoperative time and ensure enhanced clinical andradiological outcomes

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Participants in the age group of 18 – 60 years.
  • Participants with Unilateral Subcondylar fractures with more than 2 mm overlap and/or >10 degree angulation at the lower end of the condylar fragment.
  • Participants with other concomitant fractures of Mandible which will be treated by Open reduction and internal fixation
  • Participants who have sustained fracture in the past two weeks.
  • Participants with a dentition complete enough to apply a stable Erich arch bar.
  • Participants willing to participate in the study.

排除标准

  • Participants with history of uncontrolled diabetes mellitus, prolonged steroid therapy, compromised immunity and associated bone pathology.
  • Intracapsular Condylar fracture
  • Undisplaced condylar fracture.
  • Participants with history of previous Mandibular fractures or Osteotomies.
  • Subjects with bilateral condylar fracture.
  • Pregnant participants.

结局指标

主要结局

To evaluate and compare the clinical outcomes such as

时间窗: Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks

occlusion,inter incisal mouth opening, lateral excursion on

时间窗: Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks

the contralateral side, lateral excursion on the fractured

时间窗: Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks

site, protrusion, pain, edema and radiological

时间窗: Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks

outcomes such as the degree of displacement, direction

时间窗: Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks

of displacement, ramus height and the degree of

时间窗: Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks

approximation of the fractured fragment.

时间窗: Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks

次要结局

  • To evaluate and compare the intra operative time taken(for the completion of Open Reduction Internal Fixation of)

研究者

申办方类型
Other [private dental college and hospital]

研究点 (1)

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