3D Printed Models for Jaw Fractures

Enrolling by invitation at 1 trial location
DG
RR
Overseen ByReese R Triana, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Cincinnati
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if 3D printed models for planning jaw surgeries can reduce operating room time. The researchers will compare current surgery methods with those aided by a 3D-printed model to assess efficiency and effectiveness. Ideal participants include individuals with a jaw fracture who have undergone a CT scan and are receiving treatment at the University of Cincinnati Hospital. Participants will either undergo surgery with the 3D model or follow the usual care process. As an unphased trial, this study offers participants the chance to contribute to innovative surgical planning techniques that could enhance future patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this 3D printed model is safe for jaw fracture treatment?

Research has shown that 3D-printed models for jaw surgeries are safe and effective. These models simplify the surgical process by enabling doctors to plan and perform surgeries with greater precision. For instance, one study found that these models improved surgical accuracy, reducing risks during operations. Additionally, 3D models have been successfully used in other jaw surgeries, such as aligning the jaw and correcting facial defects, without major safety issues. Overall, the use of 3D models in surgery has been well-received and can lead to improved outcomes.12345

Why are researchers excited about this trial?

Researchers are excited about using 3D printed models for jaw fractures because they offer a unique advantage in surgical preparation. Unlike standard treatments, where surgeons rely solely on imaging and experience, 3D printed models provide a tangible, accurate replica of the patient’s jaw. This allows surgeons to pre-bend hardware and visualize complex fractures in a way that is not possible with traditional methods. By enhancing pre-operative planning, these models have the potential to improve surgical outcomes and reduce operation time.

What evidence suggests that 3D printed models are effective for jaw fractures?

This trial will compare the use of 3D printed models with standard care in jaw surgeries. Studies have shown that 3D printed models can make jaw surgeries more accurate and quicker. These models enable surgeons to plan and practice before the actual procedure, enhancing precision. Research indicates that these models assist in correctly placing plates to fix jaw fractures, leading to better patient outcomes. Additionally, 3D printing can create surgical tools that fit the patient perfectly, improving the effectiveness of the repair. Early findings suggest that using these models might shorten surgery time, aiding recovery.26789

Who Is on the Research Team?

DG

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

Patients who have received either a cone beam or conventional CT
Patients 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
See 1 more

Exclusion Criteria

Patients who have neither cone beam nor conventional CT
Unexpected exposure of hardware
I am under 18 years old.
See 1 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: 3D Model GeneratedExperimental Treatment1 Intervention
Group II: Normal Standards of Care without Aide of ModelActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials
442
Recruited
639,000+

Citations

Virtual reduction and 3D printing in the management of ...The authors believe this approach has potential to improve operative accuracy and reduce surgical time in these complex cases, offering good ...
Virtual Surgical Planning/3D Printing for the Management ...This study aimed to evaluate the efficacy of VSP and 3D printing in achieving accurate reduction and fixation of severely comminuted mandibular fractures.
Finite element analysis of mandibular fracture fixation ...This study aims to create an authenticated FEA model. This model was verified through a series of 3D printed mandible mechanical testing (3D-MMT) in a ...
Evaluation of accuracy of three-dimensional printing and ...The aim of this study was to assess the accuracy of virtual planning and prebinding of 3D miniplates on printed models for fixation of anterior ...
Case Report: Virtual surgery and 3D printing in a ...Results: The intraoperative result and follow-up demonstrated good accuracy of the model with respect to post-operative mandibular dynamics, ...
Outcome Evaluation of Three-Dimensionally Printed ...3D-printed patient-specific surgical plates could be applied in mandibular reconstruction safely and effectively, simplifying the surgical procedure.
The Use of 3D Model Printing for Acute Planning in Oral ...This study aimed to evaluate the use of biomodels in the surgical planning of complex fractures and the sequelae in the oromaxillofacial region.
3D planning in mandibular fractures using CAD/CAM ...The study group demonstrated superior clinical outcomes with regards to intraoperative reduction of fracture (p < 0.001; mean – 3.93, SD – 1.43), ...
The Impact of 3D Printing on Oral and Maxillofacial SurgeryThis review highlights how 3D printing is used in trauma management, surgery to align the jaw and teeth, restoration of large oral and facial defects, surgical ...
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