Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
70 participants
INTERVENTIONAL
2026-04-30
2030-08-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Industry made splint
Occlusal splints will be 3D printed by industrial third party
Industry made occlusal splint
Industry made occlusal splint
In House made splint
In house 3D printed occlusal splint
Formlabs 3D printed occlusal splint
In house 3D printed occlusal splint with Formlabs printer
Interventions
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Formlabs 3D printed occlusal splint
In house 3D printed occlusal splint with Formlabs printer
Industry made occlusal splint
Industry made occlusal splint
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Surgeons who do not perform orthognathic surgery with occlusal splints.
0 Years
80 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Robin Yang, MD, DDS
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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IRB00515012
Identifier Type: -
Identifier Source: org_study_id
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