Suez Canal University
Cairo, Egypt
Location contact
Hossam Shaban El Fadly
PRINCIPAL_INVESTIGATOR
CONTACT
CONTACT
NCT Number: NCT07280533
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Cairo, Egypt
Hossam Shaban El Fadly
PRINCIPAL_INVESTIGATOR
CONTACT
CONTACT
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Intraoperative (single measurement)
Total duration of surgery recorded in minutes from initial incision to final wound closure using the operating room timing system.
Time frame: 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).
Suez Canal University
Other
Accuracy of Virtual Surgical Planning in Reduction of Zygomatico-Maxillary Fractures A Randomized Clinical Controlled Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00583856
Craniocerebral Trauma, Facial Injuries
Sacramento, California, United States
View Trial DetailsNCT07608380
Craniocerebral Trauma, Facial Injuries
Cairo, Egypt
View Trial DetailsNCT07340528
Craniocerebral Trauma, Facial Injuries
Sohag, Egypt
View Trial DetailsNCT06600854
Craniocerebral Trauma, Facial Injuries
Toronto, Ontario, Canada
View Trial Details