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NOT YET RECRUITING
NCT07153354
NA

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

Sponsor: Mohamed abdelsalam Gaber elkhouly

View on ClinicalTrials.gov

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.

Official title: Precision of Patient-specific Screw Holes Locating Surgical Guide and Pre-bent Plates Osteosynthesis Versus Classical Workflow in the Management of Class IV Mandibular Fractures

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-10-01

Completion Date

2027-10-01

Last Updated

2025-09-03

Healthy Volunteers

No

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