Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures

King Edward Medical University

Status: Completed

Conditions: Mandibular Fractures

Treatments: Procedure: Closed Reduction & External Fixation; Procedure: Open Reduction & Internal Fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT03494309

107/RC/KEMU

Details and patient eligibility

About

Patients with mandibular sub-condylar fractures underwent either either open reduction with internal fixation (ORIF) or closed reduction with external fixation (CREF) and were followed up for 6 months to assess treatment adequacy with the hypothesis that ORIF is superior to CREF.

Enrollment: 70 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 16-60 years
• Displaced Mandibular Subcondylar Fractures(MCFs) irrespective of multiple mandibular fractures.

Exclusion criteria

• Bilateral MCFs
• MCF with mid-facial fractures
• Insufficient bilateral dentition
• Medically unfit for surgery
• Old healed mandibular fractures
• History of previous mandibular surgery for the same indication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

ORIF

Experimental group

Description:

Open Reduction \& Internal Fixation

Treatment:

Procedure: Open Reduction & Internal Fixation

CREF

Active Comparator group

Description:

Closed Reduction \& External Fixation

Treatment:

Procedure: Closed Reduction & External Fixation