MedTrace Logo

3D Printed Occlusal Splints for Intraoperative Use

NCT07079111 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-13

No results posted yet for this study

Summary

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.

Conditions

  • Malocclusion, Angle Class I
  • Malocclusion, Angle Class II
  • Malocclusion, Angle Class III

Interventions

DEVICE

Formlabs 3D printed occlusal splint

In house 3D printed occlusal splint with Formlabs printer

DEVICE

Industry made occlusal splint

Industry made occlusal splint

Sponsors & Collaborators

Principal Investigators

  • Robin Yang, MD, DDS · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-30
Primary Completion
2030-08-30
Completion
2030-08-30
FDA Device
Yes

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07079111 on ClinicalTrials.gov