Clinical trial NCT05733221: 3D Printed Models for Mandibular Fracture Repair
Official title: Determining the Ease of Utilizing 3D Printed Models to Aide in Isolated Mandibular Fracture Repair
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Mandible Fracture
Maxillofacial Trauma
Keywords: 3D Printing
Personalized Medicine
Maxillofacial Trauma
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total time in the OR
timeFrame: Total procedural time
measure: Subjective outcome to surgeon
timeFrame: Up to 2 days post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: UC Health Holmes Hospital
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Deepak G Krishnan, DDS
role: PRINCIPAL_INVESTIGATOR
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