Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures

NCT07608380 | Enrolling By Invitation DMC

• 1 other identifier: OMFS3319
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Zygomaticomaxillary Complex Fracture; Zygoma Fracture; Zygomatic Fractures

Keywords

Zygomaticomaxillary Complex Fracture; Zygoma Fracture; custom made titanium plate; virtual surgical planning; positioning guide

Outcome Measures

Primary Outcomes (2)

• Accuracy of Fracture Reduction

  Evaluation of the accuracy of fracture reduction achieved using the positioning guide and customized titanium plate. This will be assessed by superimposing the post-operative computed tomography (CT) scans onto the pre-operative virtual surgical plan. The difference will be reported as linear deviation, measured in millimeters (mm).

  one week postoperative

• Assessment of Facial Symmetry (Malar Projection)

  Evaluation of aesthetic outcome and facial symmetry by assessing the malar projection. This will be measured clinically or via imaging (e.g., comparing the fractured side to the intact side). The outcome will be reported as the linear discrepancy or difference between the two sides, measured in millimeters (mm).

  6 months postoperatively

Secondary Outcomes (3)

• Assessment of Ocular Motility and Diplopia

  6 months postoperatively

• Total Operative Time

  Day of surgery (Intraoperative)

• Patient Satisfaction

  6 months postoperatively

Study Arms (1)

Virtual Planning and Customized Plates

EXPERIMENTAL

Patients with ZMC fractures undergoing surgical treatment using 3D virtual planning and patient-specific titanium plates.

Device: Patient-specific positioning guide; Device: Customized titanium plate

Interventions

Patient-specific positioning guide DEVICE

A 3D-printed positioning guide designed through virtual surgical planning to assist in the accurate reduction of ZMC fractures.

Virtual Planning and Customized Plates

Customized titanium plate DEVICE

A custom-fabricated titanium plate designed to fit the patient's specific anatomy for rigid fixation of ZMC fractures.

Virtual Planning and Customized Plates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

department of oral and maxillofacial surgery, faculty of dentistry, Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Zygomatic Fractures

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• Prof. Ramy Ragab Elbialy, prof. of maxillofacial surgery

  Department of Oral and maxillofacial surgery,Faculty of dentistry, Cairo university

  STUDY DIRECTOR

• Dr. Mohamed Ali Zain Elabden, lecturer of maxillofacial surg

  Department of Oral and maxillofacial surgery, Faculty of dentistry, Cairo university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 27, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

EG (1)