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Patient-Specific Guides vs. Classical Workflow in Class IV Mandibular Fracture Fixation

NCT07153354 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-03

No results posted yet for this study

Summary

This study aims to overcome the limitations of current, standard approach of mandibular fracture reduction and fixation including improper alignment of segments, malocclusion, nerve affections and related teeth roots injury. The introduction of Computer Aided designing/Computer Aided manufacturing software has provided surgeons with an opportunity to perform virtual manipulations of computed tomography datasets preoperatively and production of corrected mandibular model for plate pre-bending and fabrication of plate locating surgical guide which provide accurate segment reduction and fixation with accurate post-operative occlusion and minimal post-operative complication.

Conditions

  • Mandibular Class Iv Fractures

Interventions

DEVICE

patient-specific screw holes locating surgical guide and pre-bent plates

Virtual reduction of the fracture will be done, followed by 3D printing of the corrected mandible model. Plates will be pre-bent on the model, then scanned in position to create a surgical guide for accurate screw hole placement during surgery.

DEVICE

2 titanium per-bent mini plates

The fixation will be performed according to established surgical principles for managing class iv mandibular fractures, without patient-specific planning

Sponsors & Collaborators

  • Mohamed abdelsalam Gaber elkhouly

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-10-01
Completion
2027-10-01

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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 NCT07153354 on ClinicalTrials.gov