3D Printed Models for Mandibular Fracture Repair

University of Cincinnati

Status: Invitation-only

Conditions: Maxillofacial Trauma; Mandible Fracture

Treatments: Device: 3D Printed Model

Study type: Interventional

Funder types: Other

Identifiers

NCT05733221

2022-0794

Details and patient eligibility

About

The investigators will test the hypothesis that patients randomized to the intervention (3D printing with pre-bent plate) arm have less operative room time and less time for the critical part of the procedure than patients in the control arm (no 3D printing, current standards of care). Personalized medicine and care for fracture treatment.

Full description

The goal of treatment is to re-establish the patient's preinjury dental occlusion and facial harmony. Fractures that are nondisplaced and exhibit no occlusal changes may be amenable to nonsurgical management, but most mandible fractures will require stabilization for satisfactory healing and to restore pretraumatic maxillomandibular orientation. Various treatment strategies have been described and vary widely depending on the fracture location and surgeon's preference. The patient's demographics, comorbidities, dentition, and fracture characterization will all influence the choice of fixation by the treating surgeon.

There are very few randomized control trials that show outcomes when 3D printing is used for intervention planning and performing a procedure. These data are essential to establish value of 3D printing as a clinical service. There is also anecdotal evidence that a 3D printed model of a mandible fracture can be useful for pre-operative planning because the oral and maxillofacial surgeon can better assess the geometry of the bone lesions and can pre-bend fixation plates before the procedure. This hypothetically decreases the amount of time in the operating room.

The investigators propose a parallel design randomized control trial to study the value of 3D printing for preoperative planning in patients with a fracture of the mandible who require open reduction, internal fixation. The study will be split into two arms: 1) Patients that will have a 3D model generated for the surgical procedure 2) The control group who will follow normal standards of care as outlined above and won't have the additional 3D model created pre-operatively.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patient ≥ 18 years of age

• Patients who have received either a cone beam or conventional CT
• Admitted through University of Cincinnati Hospital and Medical Center emergency department
• All isolated mandible fractures referred to University of Cincinnati Hospital Oral & maxillofacial surgery clinic
• Surgical team members from the division of plastic and otolaryngology

Exclusion criteria

• Patient < 18 years of age
• Patients who have neither cone beam nor conventional CT
• Patients requiring a repeat procedure
• Unexpected exposure of hardware

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

3D Model Generated

Experimental group

Description:

Patient will undergo an Open Reduction and Internal Fixation preformed by a surgeon who had pre-operative access to a 3D model printed to help pre-bend hardware.

Treatment:

Device: 3D Printed Model

Normal Standards of Care without Aide of Model

No Intervention group

Description:

Patient will undergo standard Open Reduction and Internal Fixation by a surgeon who did not have a pre-operative 3D model.