Comparing two different treatment methods for treating lower jaw fracture with and without the use of computerized template.

Phase 4

Completed

Conditions: Fracture of mandible,

Registration Number: CTRI/2022/09/045454

Lead Sponsor: MGM Dental College and Hospital

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 16

Inclusion Criteria

Participants in the age group of 18 â€“ 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 4.
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.

Exclusion Criteria

Participants with history of uncontrolled diabetes mellitus, prolonged steroid therapy, compromised immunity and associated bone pathology.
Intracapsular Condylar fracture 3.
Undisplaced condylar fracture.
Participants with history of previous Mandibular fractures or Osteotomies.
Subjects with bilateral condylar fracture.
Pregnant participants.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate and compare the clinical outcomes such as	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	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	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	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	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	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.	Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks

Secondary Outcome Measures

Name	Time	Method
To evaluate and compare the intra operative time taken	for the completion of Open Reduction Internal Fixation of

Trial Locations

Locations (1): MGM Dental College and Hospital
🇮🇳
Raigarh, MAHARASHTRA, India
MGM Dental College and Hospital
🇮🇳Raigarh, MAHARASHTRA, India
Ria Mukharjee
Principal investigator
8082651080
mukherjeeria95@gmail.com