Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures

Enrolling by invitation · Not applicable

Conditions studied: Zygomaticomaxillary Complex Fracture, Zygoma Fracture, Zygomatic Fractures

In brief

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.

Key facts

Study ID

NCT07608380

Run by

Cairo University

People needed

8

Starts

2025-11-01

Expected to finish

2027-09-01

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients diagnosed with Zygomatico-maxillary complex fractures requiring surgical intervention.
• Patients aged 18 years or older.
• Patients willing to provide informed consent and comply with follow-up protocols.
• Patients with adequate bone quality and quantity for stable fixation.

You may not qualify if…

• Patients with comminuted ZMC fractures that preclude the use of custom-made guides based on mirroring the contra lateral side.
• Patients with pre-existing facial deformities or asymmetries that would interfere with accurate assessment of fracture reduction.
• Patients with systemic diseases or conditions that contraindicate elective surgery or impair bone healing (e.g., uncontrolled diabetes, severe osteoporosis, active malignancy, and immunosuppression).
• Patients on medications affecting bone metabolism (e.g., long-term corticosteroids, bisphosphonates). Patients with active infections in the maxillofacial region.
• Pregnant or lactating women.
• Patients with psychiatric disorders or unrealistic expectations.
• Patients who are unable to undergo CT scans or follow post-operative instructions.

Where it is running

• department of oral and maxillofacial surgery, faculty of dentistry, Cairo university — Cairo, Egypt

Full record on ClinicalTrials.gov

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