Health TrialsbyHealthPanel

3D Printed Occlusal Splints for Intraoperative Use

ConditionsMalocclusion, Angle Class IMalocclusion, Angle Class IIMalocclusion, Angle Class III
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-80
SponsorJohns Hopkins University

About this trial

A 3D printed intraoperative occlusal splint is a custom-made biocompatible resin guide that allows surgeons properly align a patient's upper and lower dentition during surgery. This alignment further places maxilla and mandible into proper position. An occlusal splint contains outlines maxillary and mandibular dentition allowing the teeth to lock into place with correct alignment.

At Johns Hopkins, traditionally hand-made and industry-made 3D printed splints have been used safely. However, prior studies have demonstrated the ability of in-house 3D prints to save time and money compared to industry. In-house models are similarly produced with FDA-clear, biocompatible resin for 3D printing, and maintain equivalent safety for patients compared to industry-made models.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients of any age who require any orthognathic surgery (including, but not limited to, facial fracture reduction and fixation, mandibular or maxillary reconstruction, cranial vault reconstruction, mandibular osteotomies, maxilla osteotomies) at Johns Hopkins Hospital.

Disqualifiers

Patients who are non-English speaking.

Surgeons who do not perform orthognathic surgery with occlusal splints.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Formlabs 3D printed occlusal splint

    Device

    In house 3D printed occlusal splint with Formlabs printer

  • Industry made occlusal splint

    Device

    Industry made occlusal splint

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Industry made splintExperimental treatment 1 intervention
Group B: In House made splintExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time (hours) of delivery of models

Time of delivery of in-house and industry made splint models.

Time frame
Up to 1 year
2

Cost of production for oral splint models

Cost of production of in-house and industry-made models

Time frame
Up to 1 year
3

Surgeon satisfaction assessed by survey

Surgeon satisfaction between industry-made and in-house 3D printed occlusal splints. Score range between 5-20. Higher score more satisfaction.

Time frame
Post surgery up to 1 month

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: