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

NCT06588075 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-02-18

No results posted yet for this study

Summary

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.

Conditions

  • Zygomatic Fractures

Interventions

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.

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-04
Primary Completion
2025-06-01
Completion
2026-01-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06588075 on ClinicalTrials.gov