3D Printed Occlusal Splints for Intraoperative Use

NCT07079111 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB00515012
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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 II; Malocclusion, Angle Class I; Malocclusion, Angle Class III

Keywords

malocclusion

Outcome Measures

Primary Outcomes (3)

• Time (hours) of delivery of models

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

  Up to 1 year

• Cost of production for oral splint models

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

  Up to 1 year

• 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.

  Post surgery up to 1 month

Study Arms (2)

Industry made splint

EXPERIMENTAL

Occlusal splints will be 3D printed by industrial third party

Device: Industry made occlusal splint

In House made splint

EXPERIMENTAL

In house 3D printed occlusal splint

Device: Formlabs 3D printed occlusal splint

Interventions

Formlabs 3D printed occlusal splint DEVICE

In house 3D printed occlusal splint with Formlabs printer

In House made splint

Industry made occlusal splint DEVICE

Industry made occlusal splint

Industry made splint

Eligibility Criteria

• Age: 0 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Related Publications (12)

• Wezgowiec J, Malysa A, Szlasa W, Kulbacka J, Chwilkowska A, Zietek M, Wieckiewicz M. Biocompatibility of 3D-printed vs. thermoformed and heat-cured intraoral appliances. Front Bioeng Biotechnol. 2024 Oct 29;12:1453888. doi: 10.3389/fbioe.2024.1453888. eCollection 2024.

  PMID: 39534672 BACKGROUND

• Beidas T, Light L, Carrico C, Kondor S, Ravi P, Rabinowitz YA. Printing outsourced orthognathic surgical splints in-house: a dimensional verification process for point-of-care printing. 3D Print Med. 2025 Jun 6;11(1):24. doi: 10.1186/s41205-025-00276-9.

  PMID: 40478376 BACKGROUND

• Chen K, Kreh CC, Lin AY. In-House 3D Printing for Craniofacial Trauma: 7-Year Review. Ann Plast Surg. 2025 May 1;94(5S Suppl 3):S435-S440. doi: 10.1097/SAP.0000000000004281.

  PMID: 40310006 BACKGROUND

• Shilo D, Capucha T, Krasovsky A, Blanc O, Emodi O, Haze A, Rachmiel A. Real-time Reconstruction of Comminuted Mandibular Fractures Using 3D Printing. Plast Reconstr Surg Glob Open. 2024 Mar 20;12(3):e5645. doi: 10.1097/GOX.0000000000005645. eCollection 2024 Mar.

  PMID: 38510331 BACKGROUND

• DeBusk WT, Bhethanabotla RM, David AP, Heaton CM, Park AM, Seth R, Knott PD. Cost Comparison of Industry Versus In-House Three-Dimensional Printed Models for Microvascular Mandible Reconstruction. Facial Plast Surg Aesthet Med. 2025 Mar-Apr;27(2):157-162. doi: 10.1089/fpsam.2024.0172. Epub 2024 Nov 22.

  PMID: 39574355 BACKGROUND

• Marschall JS, Oppenheim MA, Kushner GM. Can a Point-of-Care 3D Printing Workflow Produce Accurate and Successful Results for Craniomaxillofacial Trauma? J Oral Maxillofac Surg. 2024 Feb;82(2):207-217. doi: 10.1016/j.joms.2023.11.006. Epub 2023 Nov 10.

  PMID: 38012957 BACKGROUND

• Ureel M, Bodere PJ, Denoiseux B, Corthouts P, Coopman R. Mandibular Reconstruction with Osseous Free Flap and Immediate Prosthetic Rehabilitation (Jaw-in-a-Day): In-House Manufactured Innovative Modular Stackable Guide System. Bioengineering (Basel). 2024 Dec 11;11(12):1254. doi: 10.3390/bioengineering11121254.

  PMID: 39768072 BACKGROUND

• Kim E, Vishwanath N, Foppiani J, Escobar-Domingo MJ, Lee D, Francalancia S, Lin GJ, Woo AS, Lin SJ. Barriers of Three-Dimensional Printing in Craniofacial Plastic Surgery Practice: A Pilot Study and Literature Review. J Craniofac Surg. 2024 Jun 1;35(4):1105-1109. doi: 10.1097/SCS.0000000000010271. Epub 2024 May 10.

  PMID: 38727233 BACKGROUND

• Oley MH, Oley MC, Sukarno V, Faruk M. Advances in Three-Dimensional Printing for Craniomaxillofacial Trauma Reconstruction: A Systematic Review. J Craniofac Surg. 2024 Oct 1;35(7):1926-1933. doi: 10.1097/SCS.0000000000010451. Epub 2024 Jul 3.

  PMID: 38958985 BACKGROUND

• Gomez VJ, Martin-Gonzalez A, Zafra-Vallejo V, Zubillaga-Rodriguez I, Fernandez-Garcia A, Sanchez-Aniceto G. In-House Virtual Surgery Planning and 3D Printing for Head and Neck Surgery With Free Software: Our Workflow. Craniomaxillofac Trauma Reconstr. 2024 Dec;17(4):331-339. doi: 10.1177/19433875231211759. Epub 2023 Nov 15.

  PMID: 39634570 BACKGROUND

• Gomez VJ, Martin-Gonzalez A, Zafra-Vallejo V, Zubillaga-Rodriguez I, Fernandez-Garcia A, Sanchez-Aniceto G. Controversies in point-of-care 3D printing for oncological and reconstructive surgery with free software in oral and maxillofacial surgery: European regulations, costs, and timeframe. Int J Oral Maxillofac Surg. 2024 Aug;53(8):650-660. doi: 10.1016/j.ijom.2024.01.005. Epub 2024 Jan 29.

  PMID: 38290865 BACKGROUND

• ElShebiny T, Simon Y, Demko CA, Palomo JM. The uses of 3-dimensional printing technology in orthodontic offices in North America. Am J Orthod Dentofacial Orthop. 2024 Jul;166(1):76-80. doi: 10.1016/j.ajodo.2024.03.014. Epub 2024 Apr 26.

  PMID: 38678454 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class I; Malocclusion, Angle Class II; Malocclusion, Angle Class III; Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Robin Yang, MD, DDS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Ren, BS

CONTACT

8457020623; tren13@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 22, 2025
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): August 30, 2030
• Study Completion (Estimated): August 30, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL