3D Printed Occlusal Splints for Intraoperative Use

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Formlabs 3D printed occlusal splint
  In house 3D printed occlusal splint with Formlabs printer
• Устройство Industry made occlusal splint
  Industry made occlusal splint

Первичные конечные точки

• Time (hours) of delivery of models [Срок оценки: Up to 1 year]
• Cost of production for oral splint models [Срок оценки: Up to 1 year]
• Surgeon satisfaction assessed by survey [Срок оценки: Post surgery up to 1 month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07079111 · IRB00515012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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