Patient-Specific Guides vs. Classical Workflow in Class IV Mandibular Fracture Fixation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: patient-specific screw holes locating surgical guide and pre-bent plates, 2 titanium per-bent mini plates.
- Who it may be relevant to
- Registry conditions: Mandibular Class Iv Fractures. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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
Primary outcome measures
- Accuracy of fracture reduction [Time frame: Within one week postoperatively]
Secondary outcome measures (2)
- Occlusion [Time frame: At 1 week, 1 month, 3 months, and 6 months postoperatively]
- Operation time [Time frame: During the surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07153354 · 3D-T4F-RCT-2025