A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures

NCT ID: NCT05695872

Last Updated: 2023-05-09

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-26

Study Completion Date

2023-02-05

Brief Summary

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The study is a randomized controlled clinical trial, following the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The study is intended to compare between the subtarsal approach, conventional transconjuctival approach and the Y- modification of the transconjuctival approach in the management of zygomatico-maxillay complex fracture.

Detailed Description

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The study is a randomized controlled clinical trial. Twenty-four patients with age range of 20-50 years requiring open reduction and fixation of a fractured zygomatic complex were randomly divided into three equal groups according to the approach used:

Group A: subtarsal approach group. Group B: conventional transconjuctival approach group. Group C: Y- modification of the transconjuctival approach group.

Conditions

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Zygomatic 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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subtarsal approach

Group Type ACTIVE_COMPARATOR

subtarsal approach

Intervention Type PROCEDURE

surgical approach

conventional transconjunctival approach

Group Type ACTIVE_COMPARATOR

conventional transconjunctival approach

Intervention Type PROCEDURE

surgical approach

transconjunctival approach with Y- modification

Group Type ACTIVE_COMPARATOR

transconjunctival approach with Y- modification

Intervention Type PROCEDURE

surgical approach

Interventions

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subtarsal approach

surgical approach

Intervention Type PROCEDURE

conventional transconjunctival approach

surgical approach

Intervention Type PROCEDURE

transconjunctival approach with Y- modification

surgical approach

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with ZMC fractures requiring open reduction and internal fixation.
* Adult patients aged between 20 and 50 years with no gender predilection.

Exclusion Criteria

* An existing laceration in the inferior and lateral periorbital site.
* Infection at the fracture line.
* Comminuted fracture with bone loss.
* Acute and chronic conjunctival diseases.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alexandria

OTHER

Sponsor Role lead

Responsible Party

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Lydia Nabil

Associate Professor of Oral and Maxillofacial Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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Melek LN, Noureldin MG. Zygomaticomaxillary complex fractures: finding the least complicated surgical approach (A Randomized Clinical Trial). BMC Oral Health. 2023 Aug 4;23(1):539. doi: 10.1186/s12903-023-03249-8.

Reference Type DERIVED
PMID: 37542217 (View on PubMed)

Other Identifiers

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UAlexandriaMaxFacSurg

Identifier Type: -

Identifier Source: org_study_id

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