A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures

University of Alexandria24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Zygomatic Fractures

Interventions

subtarsal approachPROCEDURE

surgical approach

conventional transconjunctival approachPROCEDURE

surgical approach

transconjunctival approach with Y- modificationPROCEDURE

surgical approach

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

accessibility to the fracture site

Adequate exposure provided by the incision and accessiblity to proper fracture reduction and fixation was assigned as Yes or No

Time frame: intraoperative

esthetic appearance and scarring

Postoperative scarring was recorded as noticeable or unnoticeable

Time frame: 6 weeks postoperative

radiographic verification of adequacy of fracture reduction

computed tomography was requested for adequacy of fracture reduction assessment and this outcome was assigned as Yes or No

Time frame: immediate postoperative

Secondary Outcomes

The duration for exposure of the fracture site

The duration from performing the incision till the field exposure calculated in minutes

Time frame: intraoperative

postoperative pain

Pain was evaluated at 24 hours and at 1 week according to a 10-point Visual Analogue Scale (VAS), (0-1=none,2-4=mild,5-7=moderate,8-10=severe).

Time frame: at 24 hours and 1 week

sensory nerve function

Subjective assessment of the infraorbital nerve sensation by patient questioning about any alteration in sensation at 3 months postoperatively. Objective assessment by dental probe pressure to assess sensory changes along the distribution of the infraorbital nerve with contralateral side comparison

Time frame: 3 months postoperative

Data from ClinicalTrials.gov

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