MedTrace Logo

Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures

NCT07608380 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-05-27

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the accuracy and stability of positioning guides and customized titanium plates in the treatment of Zygomaticomaxillary Complex (ZMC) fractures. The main questions it aims to answer are:

* Is the anatomical reduction achieved using a virtual planning-based positioning guide accurate when compared to preoperative plans?
* Does the customized titanium plate provide stable fixation during the follow-up period?

Researchers will compare the actual postoperative outcome to the preoperative virtual surgical plan to see if the customized workflow improves anatomical alignment.

Participants will:

* Undergo a preoperative Computed Tomography (CT) scan for virtual surgical planning.
* Receive surgical treatment using a patient-specific positioning guide and customized titanium plate.
* Complete follow-up assessments including postoperative CT scans and clinical evaluations for 6 months.

Conditions

  • Zygomaticomaxillary Complex Fracture
  • Zygoma Fracture
  • Zygomatic Fractures

Interventions

DEVICE

Patient-specific positioning guide

A 3D-printed positioning guide designed through virtual surgical planning to assist in the accurate reduction of ZMC fractures.

DEVICE

Customized titanium plate

A custom-fabricated titanium plate designed to fit the patient's specific anatomy for rigid fixation of ZMC fractures.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Prof. Ramy Ragab Elbialy, prof. of maxillofacial surgery · Department of Oral and maxillofacial surgery,Faculty of dentistry, Cairo university

  • Dr. Mohamed Ali Zain Elabden, lecturer of maxillofacial surg · Department of Oral and maxillofacial surgery, Faculty of dentistry, Cairo university

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-12-01
Completion
2027-09-01

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07608380 on ClinicalTrials.gov