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Completed

NCT Number: NCT06958510

Modified Anatomical Mesh In The Management Of Orbito-Zygomatico-Maxillary Complex Fractures

Orbito-Zygomaticomaxillary-complex fractures is a form of a complex orbital floor fracture, with affection of the inferior orbital rim and the orbital walls. According to published research, between 67 - 84 % of periorbital bone fractures are orbital floor fractures.

Evaluation of 3D-Modified Anatomic Mesh in the management of OZM- complex fractures with orbital floor defect, and compare it with the conventional fixation configuration.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

About this study

Patients suffering from OZM- complex fractures was treated using 3D-Modified Anatomical Mesh for orbital floor reconstruction and orbital rim fixation. Patients was randomly allocated into study and control groups, where it is managed with the conventional 2.0-miniplate and stock mesh. A standardized surgical protocol was followed in both groups. Patients was clinically evaluated for pain, wound healing, nerve sensation, ocular motility and diplopia, and tarsal plate morphology. Moreover, radiographic survey was performed post operatively to assess the proper positioning of the implant, to confirm proper fracture reduction, and radiographic enophthalmos analysis

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients suffering from Orbito-Zygomaticomaxillary complex fractures with fracture in the orbital floor and orbital floor defect(16).
  • Fractures that are indicated for open reduction and internal fixation.
  • Patients suffering from ocular complications:
  • Monocular diplopia.
  • Enophthalmos above 2 mm.
  • Restricted ocular motility.
  • Patients with orbital wall defects with orbital soft tissue herniation into the maxillary sinus.
  • Adult patient either male or female that agrees to present for follow-up visits for an adequate postoperative period.

Exclusion criteria

  • Patients with isolated orbital floor defects and blowout fractures.
  • Patients with isolated zygomatico-maxillary complex fracture with no orbital floor/ walls defects.
  • Patients with bilateral orbital defects.
  • Patients with Infected wounds in periorbital region.
  • Medically compromised patients rendering them inoperable.
  • Patients with ruptured globe or blindness.

Treatment and study plan

3D-Modified Anatomical-Mesh.

Device

3D-Modified Anatomical-Mesh.

conventional orbital rim miniplates and orbital mesh configuration

Device

conventional orbital rim miniplates and orbital mesh configuration

Primary outcomes

  1. Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture

    Time frame: 1 week

    Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture

Secondary outcomes

  1. Periorbital ecchymosis

    Time frame: 6 weeks

    Postoperative periorbital ecchymosis will be evaluated on a 3-points scale (0-3). The scoring system divides ecchymosis into upper and lower eyelids, and furthermore into thirds for each eyelid.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Modified Anatomical Mesh In The Management Of Orbito-Zygomatico-Maxillary Complex Fractures. A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 6, 2025
Registry last updated
Dec 31, 2025

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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