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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07788885

Enrollment

Registered

2026-08-27

Start date

2025-10-01

Completion date

2026-06-06

Last updated

2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Zygomaticomaxillary Complex (ZMC) Fractures

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.

Detailed description

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.

Interventions

DEVICECustom-made 3D-printed titanium plate

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of Anatomical Reduction	Immediate postoperative assessment and 3 months postoperative.	Accuracy of anatomical reduction assessed by comparing postoperative CT findings with the preoperative virtual surgical plan.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026