An interventional study of Formlabs 3D printed occlusal splint and Industry made occlusal splint in Malocclusion, Angle Class I, Malocclusion, Angle Class II and Malocclusion, Angle Class III, sponsored by Johns Hopkins University. Not yet recruiting. Open to participants aged 0 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
35 studies on the registry are indexed under Malocclusion, Angle Class I; 10 are open to participants now.
This study's planned enrollment of 70 is above the median of 32 across 31 interventional studies indexed under Malocclusion, Angle Class I.
Browse Malocclusion, Angle Class I studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Exclusion Criteria:
Occlusal splints will be 3D printed by industrial third party
Device: Industry made occlusal splint
In house 3D printed occlusal splint
Device: Formlabs 3D printed occlusal splint
In house 3D printed occlusal splint with Formlabs printer
Industry made occlusal splint
Time (hours) of delivery of models
Time of delivery of in-house and industry made splint models.
Time frame: Up to 1 year
Cost of production for oral splint models
Cost of production of in-house and industry-made models
Time frame: 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.
Time frame: Post surgery up to 1 month
No study locations are listed for this record.
Plan to share: Yes — Once the project has been published, a workflow will be published alongside it.
Supporting information: Study protocol
Start is estimated for Dec 2026; primary completion for Aug 2030, 44 months later.
Of 23 interventional studies with no phase under Malocclusion, Angle Class I, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 24. This study's planned 44 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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