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NCT Number: NCT05695872

A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures

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.

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Key information

Conditions

Zygomatic Fractures Craniocerebral Trauma Facial Injuries Fractures, Bone Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21526, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

subtarsal approach

Procedure

surgical approach

conventional transconjunctival approach

Procedure

surgical approach

transconjunctival approach with Y- modification

Procedure

surgical approach

Primary outcomes

  1. accessibility to the fracture site

    Time frame: intraoperative

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

  2. esthetic appearance and scarring

    Time frame: 6 weeks postoperative

    Postoperative scarring was recorded as noticeable or unnoticeable

  3. radiographic verification of adequacy of fracture reduction

    Time frame: immediate postoperative

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

Secondary outcomes

  1. The duration for exposure of the fracture site

    Time frame: intraoperative

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

  2. postoperative pain

    Time frame: at 24 hours and 1 week

    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).

  3. sensory nerve function

    Time frame: 3 months postoperative

    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

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Official study title

The Best Approach to Zygomaticomaxillary Fractures: A Comparison of Three Surgical Approaches

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2023
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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