An interventional study of Virtual surgical planning and 3D model printing and Prebent titanium miniplates in Facial Bone Fracture, Maxillofacial Injury and Zygomaticomaxillary Complex Fracture, sponsored by Suez Canal University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by Suez Canal University · Not applicable, Interventional, and Treatment
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.
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
Exclusion Criteria:
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.
Procedure: Virtual surgical planning and 3D model printing · Device: Prebent titanium miniplates
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.
Procedure: Conventional open reduction and internal fixation (ORIF) · Device: Titanium miniplates and screws (Anton Hipp)
Preoperative CT segmentation, virtual reduction of fracture fragments using 3D planning software, and printing of the reduced 3D anatomical model for plate prebending.
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.
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.
Surgeon-contoured titanium miniplates applied intraoperatively at the necessary fixation points.
Accuracy of Fracture Reduction
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.
Time frame: 3 months postoperatively
Facial symmetry
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.
Time frame: 1 week, 1 month, and 3 months postoperatively
Eye Movement (Diplopia in Gaze Positions)
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.
Time frame: 1 week and 3 months postoperatively
Postoperative Complications
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.
Time frame: Up to 3 months postoperatively
Surgical Time
Total duration of surgery recorded in minutes from initial incision to final wound closure using the operating room timing system.
Time frame: Intraoperative (single measurement)
Bone Healing
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).
Time frame: 3 months postoperatively
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Maxillofacial Injuries
Suez Canal University