Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures

King Edward Medical University70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mandibular Fractures

Interventions

Open Reduction & Internal FixationPROCEDURE

Patients underwent surgery and the fractures were reduced under direct vision followed by internal fixation with titanium plates and screws

Closed Reduction & External FixationPROCEDURE

Patients underwent closed reduction of the fracture and external fixation by arch bars \& guided elastics

Eligibility

Sex: ALLMin age: 16 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mouth Opening

Mouth Opening shall be determined by measuring the maximal distance between the edges of upper and lower incisors with fully opened mouth; the measurement shall be made in millimeters (mm) using vernier caliper and mouth opening of 35 mm or more shall be classified as "adequate"

Time frame: 6 months

Occlusion

Occlusion shall be determined by maximum "inter-cuspation" as observed by the surgeon and patient self-reporting and will be classified as fine or deranged.

Time frame: 6 months

Secondary Outcomes

Complications

The frequency of complications with either mode of treatment shall be recorded

Time frame: 6 months

Cost-Effectiveness

Cost-Effectiveness shall be determined as the ratio of the cost of treatment and achievement of both adequate mouth opening and fine occlusion. The cost of treatment shall include the cost of surgical items (wires, elastics, arch bars, plates, screws etc), cost of anesthesia and surgery, cost of hospital stay and cost of follow up.

Time frame: 6 months

Patient Satisfaction

Participants shall be requested to report their satisfaction after treatment with regards to ease of chewing, mouth opening \& closing and achievement of pre0traumatic facial symmetry/orientation. This parameter shall be recorded on a 4-point Likert scale (not satisfied, somewhat dissatisfied, somewhat satisfied, satisfied).

Time frame: 6 months

Data from ClinicalTrials.gov

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