3D Printed Models for Mandibular Fracture Repair

NCT05733221 | Enrolling By Invitation FDA Device

• 1 other identifier: 2022-0794
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Mandible Fracture; Maxillofacial Trauma

Keywords

3D Printing; Personalized Medicine; Maxillofacial Trauma

Outcome Measures

Primary Outcomes (2)

• Total time in the OR

  Time in the OR considered critical part of the procedure by the Oral \& Maxillofacial Surgery Staff

  Total procedural time

• Subjective outcome to surgeon

  Surgeon overall satisfaction with utilizing the 3D generated model, obtained via Likert Scale Questions completed post-operatively. The investigators are going to use the Likert questions to develop a numerical scoring system and report that data as "raw" Likert scores. Likert questions and conversion of specialists' responses to Anatomic Model Utility Points (AMUPs). Responses of "strongly disagree", "disagree", and "neutral" were assigned 0 AMUP points. Responses to preprocedural confidence are assigned negative points, to effectively subtract the impact of the anatomic model post- versus pre-procedure. The maximum AMUP for each patient was 500.

  Up to 2 days post-procedure

Study Arms (2)

3D Model Generated

EXPERIMENTAL

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.

Device: 3D Printed Model

Normal Standards of Care without Aide of Model

NO INTERVENTION

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

Interventions

3D Printed Model DEVICE

3D Printed Model generated pre-operatively of the patients mandible.

3D Model Generated

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (2)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

UC Health Holmes Hospital

Cincinnati, Ohio, 45220, United States

Location

Related Publications (25)

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MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• Deepak G Krishnan, DDS

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Once the subjects are identified the research coordinator will conduct a screening of the patient to ensure they meet the inclusion/ exclusion criteria for the study and then randomize the patient into either normal standard of care for surgical repair of the fractured mandible or normal standard of care for surgical repair of the fractured mandible aided by a 3D printed model of the patient's jaw.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Oral & Maxillofacial Surgery

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 17, 2023
• Study Start: March 11, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)