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3D Printed Models for Jaw Fractures
N/A
Waitlist Available
Led By Deepak G Krishnan, DDS
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 days post-procedure
Awards & highlights
No Placebo-Only Group
Summary
This trial tests personalized care for fracture treatment: 3D printing customized plates to reduce time in the OR and critical procedure stages.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves surgical procedures, potential side effects may include typical surgical risks such as infection, bleeding, pain at the site of surgery, swelling, and possible complications related to anesthesia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ total procedural time
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~total procedural time
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Subjective outcome to surgeon
Total time in the
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 3D Model GeneratedExperimental Treatment1 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 ModelActive Control1 Intervention
Patient will undergo standard Open Reduction and Internal Fixation by a surgeon who did not have a pre-operative 3D model.
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Who is running the clinical trial?
University of CincinnatiLead Sponsor
439 Previous Clinical Trials
638,648 Total Patients Enrolled
Deepak G Krishnan, DDSPrincipal InvestigatorUniversity of Cincinnati
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I need another surgery or procedure.I am 18 years old or older.My surgery team includes plastic and ear, nose, throat specialists.
Research Study Groups:
This trial has the following groups:- Group 1: 3D Model Generated
- Group 2: Normal Standards of Care without Aide of Model
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.