A Full Digital VS Conventional Protocol in Management of Zygomatico-Maxillary Complex Fracture

February 16, 2026 updated by: Dina Ayman Fayek, Cairo University

Evaluation of the Accuracy of Zygomatico-Maxillary Complex Fracture Reduction And Fixation Using A Full Digital Workflow Versus Conventional Protocol: A Randomized Clinical Trial

this study aims To evaluate The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fracture reduction and fixation Using customized Patient-Specific implant and patient-specific predictive holes surgical guide Versus Conventional Technique of reduction and fixation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The ZMC has multiple points of articulation with the craniofacial skeleton making accurate assessment of reduction at all articulations intraoperative in multiple planes very challenging and the interference of soft tissue edema and a narrowed visual field increases the possibility of intraoperative overcorrection or underestimation of pre-injured position of all fracture lines at the same time resulting in a suboptimal reduction. As a trial to maximize the benefits of digital planning carrying the plan into a real operating room using a patient-specific surgical guide to predrill screw holes and guide patient-specific implants during fixation according to the planning depend on CT scan.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 12613
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Zygomatic Fracture Types III, IV, V, VII, and VIII according to Rowe and Killey's classification.
  • Age range (18-60 years).
  • Patients are willing for the surgical procedure and follow-up, with informed consent

Exclusion Criteria:

  • Zygomatic Fracture Type I, II according to Rowe and Killey's classification.
  • Patients with contraindications for general anesthesia.
  • Patient on radiotherapy.
  • Patients suffer from bone disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
all cases that will be allocated in this group will undergo treatment using a full digital protocol depending on planning software and the planning will be carried out into the operating room using 3D printed predictive holes surgical guides to determine accurately the optimum position of customized plates
Procedure: Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flow
All surgeries will be carried out under general anesthesia the fracture lines will be exposed then For the study group: following the exposure of all fracture lines , anatomically seated bone-supported predictive holes surgical guides will be inserted on the bone segments with intimate contact. Each segment hole will be drilled according to the predesigned predictive holes guide. The fractured segments will then be reduced and fixed using titanium miniplates customized for the patient and screws at least two screws for each fracture segment. then closure in layers will be performed using absorbable vicryl for deep layers and intraoral sutures and non-absorbable polyproline for skin closure.
Active Comparator: control group
patients in this group will be treated using a conventional protocol of reduction depending on visualization intraoperative and tactile sensation and will be fixed using a stock miniplates and screws.
Procedure: Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocol
For the control group: all cases will be treated under general anesthesia and the fracture lines will be exposed then the conventional protocol of treatment depend mainly on visualization of the fracture line and tactile sensation of the operator intra-operative during reduction procedure and the fixation of fractured segments will be done using titanium miniplates and screws then closure in layers will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Zygomatic reposition
Time Frame: immediate postoperative
the accuracy of zygomatic bone reduction and fixation using postoperative CT scan
immediate postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative time
Time Frame: during the operation
duration of operation using stopwatch
during the operation
paresthesia
Time Frame: pre operative, immediate postoperative and 6 months post operative
sensation in the area supplied by the infraorbital nerve using a 2 points discrimination test
pre operative, immediate postoperative and 6 months post operative
patient satisfaction
Time Frame: 6 months postoperative
patient aesthetic satisfaction will be measured using a visual analogue scale from 0 to 10 in a questionnaire form, zero mean not satisfied at all and 10 is the maximum satisfaction.
6 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Dina Ayman Fayek, M.Sc, Assistant lecturer oral and maxillofacial surgery department Future university in Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2024

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

September 5, 2024

First Submitted That Met QC Criteria

September 6, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMFS 3319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

the data will be available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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