Malocclusion, Angle Class INCT07079111
3D Printed Occlusal Splints for Intraoperative Use
A study testing Formlabs 3D printed occlusal splint and Industry made occlusal splint in people with Malocclusion, Angle Class I and Malocclusion, Angle Class II, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 80 years
- Conditions the study is for
- Malocclusion, Angle Class I, Malocclusion, Angle Class II, Malocclusion, Angle Class III
- What is being tested?
- Formlabs 3D printed occlusal splint and Industry made occlusal splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2026to 30 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who are non-English speaking.
- Surgeons who do not perform orthognathic surgery with occlusal splints.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Being tested
- Formlabs 3D printed occlusal splint, Industry made occlusal splint
- Keywords
- malocclusion
- Medical subject headings
- Malocclusion, Angle Class I, Malocclusion, Angle Class II, Malocclusion, Angle Class III, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formlabs 3D printed occlusal splintDevice
In house 3D printed occlusal splint with Formlabs printer
Industry made occlusal splintDevice
Industry made occlusal splint
| Study group | Role | What they receive |
|---|---|---|
| Industry made splint | Experimental | Occlusal splints will be 3D printed by industrial third party Receives: Device: Industry made occlusal splint |
| In House made splint | Experimental | In house 3D printed occlusal splint Receives: Device: Formlabs 3D printed occlusal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (hours) of delivery of models
Time of delivery of in-house and industry made splint models.
Measured: Up to 1 year
Cost of production for oral splint models
Cost of production of in-house and industry-made models
Measured: 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.
Measured: Post surgery up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start30 Dec 2026 (estimated)
- Primary completion30 Aug 2030 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Angle Class IStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin Yang, MD, DDS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079111
- Sponsor's protocol ID
- IRB00515012
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Once the project has been published, a workflow will be published alongside it.
Publications
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.
PubMed 39534672Beidas 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.
PubMed 40478376Chen 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.
PubMed 40310006Shilo 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.
PubMed 38510331DeBusk 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.
PubMed 39574355Marschall 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.
PubMed 38012957Ureel 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.
PubMed 39768072Kim 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.
PubMed 38727233Oley 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.
PubMed 38958985Gomez 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.
PubMed 39634570Gomez 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.
PubMed 38290865ElShebiny 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.
PubMed 38678454
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printed Occlusal Splints for Intraoperative Use
- ClinicalTrials.gov ID
- NCT07079111
- Acronym / sponsor ID
- IRB00515012
- Keywords
- malocclusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 30 Aug 2030 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Industry made splint | Experimental | Device: Industry made occlusal splintOcclusal splints will be 3D printed by industrial third party |
| In House made splint | Experimental | Device: Formlabs 3D printed occlusal splintIn house 3D printed occlusal splint |
Who may qualify
- Ages
- 0 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who are non-English speaking.
- Surgeons who do not perform orthognathic surgery with occlusal splints.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formlabs 3D printed occlusal splintIn house 3D printed occlusal splint with Formlabs printer | Device | In House made splint |
| Industry made occlusal splintIndustry made occlusal splint | Device | Industry made splint |
Primary outcome
Time (hours) of delivery of models
Time frame: Up to 1 year
Time of delivery of in-house and industry made splint models.
Cost of production for oral splint models
Time frame: Up to 1 year
Cost of production of in-house and industry-made models
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 39534672Wezgowiec 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.
- Background: PubMed 40478376Beidas 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.
- Background: PubMed 40310006Chen 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.
- Background: PubMed 38510331Shilo 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.
- Background: PubMed 39574355DeBusk 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.
- Background: PubMed 38012957Marschall 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.
- Background: PubMed 39768072Ureel 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.
- Background: PubMed 38727233Kim 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.
- Background: PubMed 38958985Oley 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.
- Background: PubMed 39634570Gomez 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.
- Background: PubMed 38290865Gomez 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.
- Background: PubMed 38678454ElShebiny 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.
- Individual participant dataSharing planned: Yes. Once the project has been published, a workflow will be published alongside it.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robin Yang, MD, DDS principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Formlabs 3D printed occlusal splint and Industry made occlusal splint in people with Malocclusion, Angle Class I and Malocclusion, Angle Class II, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Ren, BS (8457020623, tren13@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (hours) of delivery of models (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07079111, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.