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

NCT07788885 | Completed DMC

• 1 other identifier: Evaluation of Custom-Made Plat
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Zygomaticomaxillary Complex (ZMC) Fractures

Outcome Measures

Primary Outcomes (1)

• Accuracy of Anatomical Reduction

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

  Immediate postoperative assessment and 3 months postoperative.

Study Arms (1)

Custom-Made 3D-Printed Titanium Plate

EXPERIMENTAL

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.

Device: Custom-made 3D-printed titanium plate

Interventions

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.

Custom-Made 3D-Printed Titanium Plate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

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

Asyut, Assuit, 71511, Egypt

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Evaluation of Custom-Made Plates in the Treatment of Zygomatico- Maxillary Complex (ZMC) Fractures.

Model Details: All participants underwent surgical fixation of unilateral ZMC fractures using custom-made 3D-printed titanium plates.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: October 1, 2025
• Primary Completion: June 6, 2026
• Study Completion: June 6, 2026
• Last Updated: August 27, 2026

Record last verified: 2025-10

Locations

EG (1)