Evaluation of Custom-Made Plates in the Treatment of Zygomaticomaxillary Complex (ZMC) Fractures.

This prospective, single-arm clinical trial evaluated the clinical and radiographic outcomes of custom-made, 3D-printed titanium plates in the surgical treatment of unilateral zygomaticomaxillary complex (ZMC) fractures. The study assessed the accuracy of anatomical reduction, postoperative functional and esthetic outcomes, surgical efficiency, patient satisfaction, and postoperative complications.

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Key information

Conditions

Zygomaticomaxillary Complex (ZMC) Fractures Fractures, Bone Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oral and Maxillofacial Surgery, Faculty of Dental Medicine, Al-Azhar University - Assiut Branch

Asyut, Assuit, 71511, Egypt

About this study

Patients with unilateral ZMC fractures requiring open reduction and internal fixation underwent virtual surgical planning based on preoperative CT imaging. Custom-made 3D-printed titanium plates were designed according to the patient's anatomy and used for fracture fixation. Clinical and radiographic outcomes were assessed postoperatively at 1 week, 1 month, and 3 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age 18-50 years. Unilateral ZMC fractures indicated for open reduction and internal fixation (ORIF).

Medically fit for general anesthesia. Trauma occurring within 10 days. Commitment to 3 months of follow-up.

Exclusion criteria

Exclusion Criteria Bilateral or panfacial fractures. Pathological fractures or previous ZMC surgery. Systemic disease affecting bone healing. Patients refusing consent. Sex: All

Treatment and study plan

Custom-made 3D-printed titanium plate

Device

Custom-made 3D-printed titanium plates designed through virtual surgical planning based on preoperative CT imaging. The healthy side was mirrored to assist in virtual reconstruction and plate design. The plates were fabricated from biocompatible titanium and sterilized before surgery.

Primary outcomes

Accuracy of Anatomical Reduction

Time frame: Immediate postoperative assessment and 3 months postoperative.

Accuracy of anatomical reduction assessed by comparing postoperative CT findings with the preoperative virtual surgical plan.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Evaluation of Custom-Made Plates in the Treatment of Zygomaticomaxillary Complex (ZMC) Fractures

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Aug 27, 2026
Registry last updated: Aug 27, 2026

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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Completed