Facial Bone Fracture, Maxillofacial Injury, Zygomaticomaxillary Complex Fracture
Conditions
Keywords
Zygomaticomaxillary complex fracture, ZMC fracture, Virtual surgical planning, 3D printing, Prebent titanium miniplates, Facial symmetry, Computer-assisted surgery, CT evaluation, Traditional surgical method
Brief summary
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.
Detailed 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
Interventions
PROCEDUREVirtual surgical planning and 3D model printing
Preoperative CT segmentation, virtual reduction of fracture fragments using 3D planning software, and printing of the reduced 3D anatomical model for plate prebending.
DEVICEPrebent titanium miniplates
Titanium miniplates prebent on the printed model and used for rigid internal fixation at standard zygomatic fixation points (frontozygomatic suture, infraorbital rim, zygomaticomaxillary buttress) as indicated.
PROCEDUREConventional open reduction and internal fixation (ORIF)
Standard surgical exposure and manual reduction of fracture fragments with intraoperative confirmation of alignment, followed by contouring and application of titanium miniplates and screws for fixation.
DEVICETitanium miniplates and screws (Anton Hipp)
Surgeon-contoured titanium miniplates applied intraoperatively at the necessary fixation points.
Sponsors
Suez canal university hospitals
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
clinical trial compares two different surgical approaches for treating zygomaticomaxillary complex (ZMC) fractures): Experimental Arm (Group I): Virtual surgical planning (VSP) with 3D model printing and prebent titanium miniplates. Active Comparator Arm (Group II): Traditional open reduction and fixation without virtual planning or prebent plates.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Fracture Reduction | 3 months postoperatively | Measurement of the 3D linear discrepancy (in millimeters) between the postoperative CT model and the preoperative virtual reduction model using surface-based 3D superimposition (color-map deviation analysis). The mean deviation (mm) will be automatically calculated by the 3D analysis software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Facial symmetry | 1 week, 1 month, and 3 months postoperatively | Measurement of midline deviation and the distance (mm) from facial midline to the most lateral point of the malar eminence on both sides using standardized frontal photographs. Symmetry is expressed as the absolute difference in millimeters. |
| Eye Movement (Diplopia in Gaze Positions) | 1 week and 3 months postoperatively | Number of the 9 standard gaze positions in which the participant reports diplopia during clinical examination. The examiner will assess ocular motility in primary position, up gaze, down gaze, right gaze, left gaze, and the 4 oblique gaze positions. Diplopia will be recorded as present or absent in each position, producing a total score from 0 to 9. |
| Postoperative Complications | Up to 3 months postoperatively | Number of participants developing postoperative complications including infection, wound dehiscence, trismus, or sensory deficit. Each complication will be recorded as yes/no for each patient. |
| Surgical Time | Intraoperative (single measurement) | Total duration of surgery recorded in minutes from initial incision to final wound closure using the operating room timing system. |
| Bone Healing | 3 months postoperatively | Radiographic assessment of bone healing using postoperative CT. Bone union will be scored using a standardized 4-point CT bone healing scale (0 = no healing, 3 = complete cortical continuity). |
Countries
Egypt
Outcome results
None listed