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

NCT ID: NCT07153354

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-10-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Patients In this group will be reduced using patient computer-guided specific screw holes locating guide and pre-bent plates(2.3 for inferior border and 2.0 for superior border)

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

classical work-flow

Patients In this group will be reduced by classical reduction and fixation protocol

Group Type: ACTIVE_COMPARATOR

2 titanium per-bent mini plates

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with delayed mandibular class IV fracture need open reduction and internal fixation.
• Patients with a medical history that did not hinder plate placement (uncontrolled diabetes) and adequate proper oral hygiene.
• Both genders, males and females, will be included

Exclusion Criteria

• General contraindications to surgery.
• Patients with unfavorable or comminuted fractures.
• Subjected to irradiation in the head and neck area less than 1 year before fixation.
• Poor oral hygiene and motivation.
• Uncontrolled diabetes.
• Pregnant or nursing.
• Substance abuse.
• Psychiatric problems or unrealistic expectations.
• Severe bruxism or clenching.
• Immunosuppressed or immunocompromised.
• Treated or under treatment with intravenous amino-bisphosphonates.
• Patients participating in other studies, if the present protocol could not be properly followed.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mohamed abdelsalam Gaber elkhouly

OTHER

Sponsor Role: lead

Responsible Party

Mohamed abdelsalam Gaber elkhouly

Resident oral and maxillo-facial surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Mohamed Abelsalam Gaber Elkhouly

Role: CONTACT

mohamed.gaber@dentistry.cu.edu.eg

01009837389

Other Identifiers

3D-T4F-RCT-2025

Identifier Type: -

Identifier Source: org_study_id