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Clinical Performance of CAD/CAM Occlusal Splints Fabricated With or Without Wax Bite Registration in Healthy Adults
Sponsor: Radboud University Medical Center
Summary
Occlusal splints are commonly used to manage sleep bruxism, temporomandibular disorders, and tooth wear. Traditionally, a wax bite registration is used during the fabrication of CAD/CAM occlusal splints to determine the vertical dimension and occlusal relationship. New digital techniques allow the splint to be designed without a wax bite registration by virtually increasing the vertical dimension based on maximal occlusion. This randomized crossover study compares these two fabrication workflows in healthy volunteers. Participants will wear both splints in random order. The study will evaluate patient-reported comfort and clinical performance, including occlusal contacts, force distribution, splint stability, and the occlusal adjustments required at insertion.
Official title: Clinical Performance of CAD/CAM Occlusal Splints Fabricated With or Without Wax Bite Registration: A Randomized Crossover Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2026-09-01
Completion Date
2027-01-31
Last Updated
2026-07-22
Healthy Volunteers
Yes
Interventions
Occlusal splint fabricated using a virtual increase of the vertical dimension
Intervention 1: CAD/CAM occlusal splint fabricated using a virtual increase of the vertical dimension CAD/CAM-milled occlusal splint fabricated from PMMA using a fully digital workflow. The splint is designed by virtually increasing the vertical dimension based on the participant's maximal intercuspation, without the use of a conventional wax bite registration. Participants will wear the splint overnight for 3 weeks (minimum 6 hours per night).
Occlusal splint fabricated using a conventional wax bite registration
Intervention 2: CAD/CAM occlusal splint fabricated using a conventional wax bite registration CAD/CAM-milled occlusal splint fabricated from the same PMMA material using a conventional wax bite registration to determine the vertical dimension and occlusal relationship during the digital design process. Participants will wear the splint overnight for 3 weeks (minimum 6 hours per night).
Locations (1)
RadboudUMC
Nijmegen, Gelderland, Netherlands