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NCT Number: NCT07079111

3D Printed Occlusal Splints for Intraoperative Use

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.

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Key information

Age range

0 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Treatment of dentofacial deformities requires restoration of occlusion. Occlusal splints stabilize the jaws intraoperatively to restore occlusion, which improve functions such as mastication, speech, breathing, and appearance.

Orthodontic resins and denture material have been used to fabricate dental splints due to the biocompatibility nature and ease of use. These materials, throughout the years, have been found to have structural stability, used for various purposes including nightguards, occlusal splints, etc. In recent years with the advanced of computer automated design (CAD/CAM), these splints have been outsourced to industry manufacturers.

Industry-made printed splints are costly and time-consuming, highlighting the need for faster, more affordable solutions. In-house printed splints have demonstrated consistent uniformity with negligible differences in shape to the source files. The investigators hypothesize that in-house printed models will be at least as effective as industry-made models in the application of acute craniofacial trauma while decreasing costs and production time.

This study evaluates the feasibility and benefits of in-house 3D printed occlusal splints. By using the same printers and biocompatible resin as industry manufacturers12, in-house splints maintain patient safety, while reducing hospital stay durations, lowering infection rates, and increasing hospital turnover. This approach could improve surgical efficiency and patient outcomes, offering a cost-effective alternative in mandibular surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients who are non-English speaking.
  • Surgeons who do not perform orthognathic surgery with occlusal splints.

Treatment and study plan

Formlabs 3D printed occlusal splint

Device

In house 3D printed occlusal splint with Formlabs printer

Industry made occlusal splint

Device

Industry made occlusal splint

Primary outcomes

  1. Time (hours) of delivery of models

    Time frame: Up to 1 year

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

  2. Cost of production for oral splint models

    Time frame: Up to 1 year

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

  3. Surgeon satisfaction assessed by survey

    Time frame: Post surgery up to 1 month

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

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Ren, BS

CONTACT

[email protected]

8457020623

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jul 22, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.