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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045454

Enrollment

Registered

2022-09-13

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S026- Fracture of mandible

Interventions

Intervention1: Virtual Surgical Planning followed by fabrication of a Surgical Template: Fixation of subcondylar fracture of mandible using Virtual Surgical Planning followed by fabrication of a Sur

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants in the age group of 18 – 60 years. 2. Participants with Unilateral Subcondylar fractures with more than 2 mm overlap and/or >10 degree angulation at the lower end of the condylar fragment. 3. 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. 5. Participants with a dentition complete enough to apply a stable Erich arch bar. 6. Participants willing to participate in the study

Exclusion criteria

Exclusion criteria: 1. Participants with history of uncontrolled diabetes mellitus, prolonged steroid therapy, compromised immunity and associated bone pathology. 2. Intracapsular Condylar fracture 3. Undisplaced condylar fracture. 4. Participants with history of previous Mandibular fractures or Osteotomies. 5. Subjects with bilateral condylar fracture. 6. Pregnant participants

Design outcomes

Primary

Measure	Time frame
To evaluate and compare the clinical outcomes such as occlusion,inter incisal mouth opening, lateral excursion on the contralateral side, lateral excursion on the fractured site, protrusion, pain, edema and radiological outcomes such as the degree of displacement, direction of displacement, ramus height and the degree of approximation of the fractured fragment.Timepoint: Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks	—

Measure

Time frame

To evaluate and compare the clinical outcomes such as occlusion,inter incisal mouth opening, lateral excursion on the contralateral side, lateral excursion on the fractured site, protrusion, pain, edema and radiological outcomes such as the degree of displacement, direction of displacement, ramus height and the degree of approximation of the fractured fragment.Timepoint: Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks

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Secondary

Measure	Time frame
To evaluate and compare the intra operative time taken for the completion of Open Reduction Internal Fixation of Unilateral Subcondylar Fracture With and Without the Use of Virtual Surgical Planning and Surgical Template.Timepoint: Intra-operative time : Surgical parameter for evaluation will be based on operative time recorded in minutes from the time of exposure of the fracture upto the drilling of the last screw	—

Measure

Time frame

To evaluate and compare the intra operative time taken for the completion of Open Reduction Internal Fixation of Unilateral Subcondylar Fracture With and Without the Use of Virtual Surgical Planning and Surgical Template.Timepoint: Intra-operative time : Surgical parameter for evaluation will be based on operative time recorded in minutes from the time of exposure of the fracture upto the drilling of the last screw

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Countries

India

Contacts

Public ContactDr Srivalli Natarajan

MGM dental college and hospital

srivalli.shrikanth@gmail.com9769088803

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026