Accuracy of Virtual Surgical Planning Versus Traditional Technique in Zygomaticomaxillary Fracture Reduction

Suez Canal University

Status: Not yet enrolling

Conditions: Maxillofacial Injury; Facial Bone Fracture; Zygomaticomaxillary Complex Fracture

Treatments: Device: Prebent titanium miniplates; Procedure: Conventional open reduction and internal fixation (ORIF); Procedure: Virtual surgical planning and 3D model printing; Device: Titanium miniplates and screws (Anton Hipp)

Study type: Interventional

Funder types: Other

Identifiers

NCT07280533

1002/2025

Details and patient eligibility

About

This randomized clinical trial aims to evaluate the accuracy and outcomes of virtual surgical planning (VSP) compared to the traditional surgical technique in the reduction of zygomaticomaxillary complex (ZMC) fractures. Twenty patients with ZMC fractures will be randomly assigned into two equal groups: one treated using virtual planning and prebent titanium miniplates, and the other treated conventionally without virtual planning. Clinical evaluation will include facial symmetry, eye movement, and postoperative complications, while radiographic assessment will be performed using CT scans three months after surgery to measure bone formation and alignment accuracy. The study seeks to determine whether virtual surgical planning improves anatomical restoration, esthetics, and functional outcomes compared to traditional methods.

Full description

Background:

The zygomaticomaxillary complex (ZMC) is one of the most frequently fractured regions of the facial skeleton due to its prominent anatomical position. Improper reduction can lead to functional impairment, facial asymmetry, and poor esthetic results. Virtual surgical planning (VSP) and 3D printing have recently been introduced to enhance surgical precision through preoperative simulation and prebending of fixation plates. However, the clinical superiority of this technique over traditional surgical methods remains under investigation.

Objective:

To compare the accuracy and clinical outcomes of virtual surgical planning and prebent titanium miniplates versus conventional open reduction and internal fixation techniques in the management of zygomaticomaxillary complex fractures.

Methods:

This randomized clinical trial will include 20 patients diagnosed with unilateral ZMC fractures, divided equally into two groups.

Group I: Patients treated using virtual surgical planning with 3D model reconstruction, virtual reduction, and prebending of titanium miniplates.

Group II: Patients treated using traditional open reduction and fixation without virtual planning.

All surgeries will be performed under general anesthesia using standard approaches. Clinical evaluation will include assessment of facial symmetry, eye movement, enophthalmos, diplopia, wound healing, and postoperative complications. Radiographic evaluation will be conducted by comparing postoperative 3D CT scans (after 3 months) with preoperative virtual models to assess reduction accuracy and bone formation.

Statistical Analysis:

Data will be analyzed using SPSS software. Descriptive statistics will be presented as mean ± standard deviation. Independent t-tests and ANOVA will be used to compare outcomes between groups, with significance set at p ≤ 0.05.

Expected Outcomes:

It is anticipated that virtual surgical planning will yield superior anatomical accuracy, improved facial symmetry, and reduced intraoperative time and complications compared to conventional techniques.

Ethical Approval:

Approved by the Research Ethics Committee, Faculty of Dentistry, Suez Canal University, on 30 September 2025 (Board Status: Approved).

Study Start Date: October 2025 Estimated Completion Date: October 2026

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults (≥18 years) with clinically and radiographically confirmed ZMC fracture.
• Fit for general anesthesia and able to undergo CT imaging.
• Willing to sign informed consent.

Exclusion criteria

• Systemic diseases impairing bone healing (osteoporosis, cancer, long-term steroid use).
• Noncompliance or inability to attend follow-up visits.
• ASA class IV-VI.
• Previous facial deformities or fractures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Virtual Surgical Planning (VSP) - Prebent Miniplates

Experimental group

Description:

Patients allocated to this arm will undergo preoperative CT segmentation and 3D reconstruction, virtual reduction of the zygomaticomaxillary complex, and 3D printing of the reduced model. Titanium miniplates will be prebent on the 3D printed model before surgery. Surgical fixation will then be performed under general anesthesia using the prebent titanium miniplates.

Treatment:

Procedure: Virtual surgical planning and 3D model printing

Device: Prebent titanium miniplates

Traditional Open Reduction and Fixation

Active Comparator group

Description:

Patients allocated to this arm will undergo conventional open reduction and internal fixation of the ZMC fracture under general anesthesia without prior virtual surgical planning or 3D-printed models. Titanium miniplates will be contoured intraoperatively by the surgical team and used for fixation at the appropriate sites.

Treatment:

Device: Titanium miniplates and screws (Anton Hipp)

Procedure: Conventional open reduction and internal fixation (ORIF)