3D Printed Models for Jaw Fractures

Recruiting at 1 trial location

Overseen By Reese R Triana, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Under 18, No CT, Repeat procedure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Deepak G Krishnan, DDS

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

This trial is for adults over 18 with jaw fractures who are treated at the University of Cincinnati Hospital. They must have been admitted through the emergency department and referred to the oral & maxillofacial surgery clinic, having received a specific type of CT scan.

Inclusion Criteria

All isolated mandible fractures referred to University of Cincinnati Hospital Oral & Maxillofacial Surgery clinic

Patients who have received either a cone beam or conventional CT

Patients admitted through University of Cincinnati Hospital and Medical Center emergency department

Exclusion Criteria

I am under 18 years old.

Patients who have neither cone beam nor conventional CT

Unexpected exposure of hardware

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Planning

3D models are generated for pre-operative planning to help pre-bend hardware for the surgical procedure

1 week

Treatment

Patients undergo Open Reduction and Internal Fixation, with or without the aid of a 3D model

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surgeon satisfaction with the 3D model

Up to 2 days post-procedure

What Are the Treatments Tested in This Trial?

Interventions

• 3D Printed Model

Trial Overview The study is testing if using a 3D printed model to pre-bend plates for mandibular fracture repair reduces time in the operating room compared to standard care without 3D printing.

How Is the Trial Designed?

Group I: 3D Model Generated Experimental Treatment 1 Intervention

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.

Group II: Normal Standards of Care without Aide of Model Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+