Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures

NCT ID: NCT03494309

Last Updated: 2018-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-01

Study Completion Date

2015-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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Mandibular Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ORIF

Open Reduction \& Internal Fixation

Group Type EXPERIMENTAL

Open Reduction & Internal Fixation

Intervention Type PROCEDURE

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

CREF

Closed Reduction \& External Fixation

Group Type ACTIVE_COMPARATOR

Closed Reduction & External Fixation

Intervention Type PROCEDURE

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

Interventions

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Open Reduction & Internal Fixation

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

Intervention Type PROCEDURE

Closed Reduction & External Fixation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Edward Medical University

OTHER

Sponsor Role lead

Responsible Party

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Samira S Baloch

Assistant Professor of Oral & Maxillofacial Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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107/RC/KEMU

Identifier Type: -

Identifier Source: org_study_id

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