Clinical Trial

3D Printed Occlusal Splints for Intraoperative Use

Not Yet Recruiting
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-07-21; most recent amendment 2026-04-09.
Trial Details
NCT Number NCT07079111
Lead Sponsor Johns Hopkins University
Conditions Malocclusion, Angle Class I, Malocclusion, Angle Class II, Malocclusion, Angle Class III
Enrollment 70 participants
Start Date 2026-12-30
Primary Completion 2030-08-30 (estimated)
Study Completion 2030-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-11