Clinical Trial

Clinical Performance of CAD/CAM Occlusal Splints Fabricated With or Without a Wax Bite Registration in Healthy Adults

Study acronym: Splint
Not Yet Recruiting
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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 intercuspation. 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 during insertion
Protocol Amendment History 2 changes
critical Phase changed: not specified -> not applicable 2026-07-28
minor Trial arms changed: 0 -> 2 2026-07-28
Trial Details
NCT Number NCT07720453
Lead Sponsor Radboud University Medical Center
Conditions Occlusion, Occlusal Splints, Occlusal Analysis, Comfort
Enrollment 30 participants
Start Date 2026-09-01
Primary Completion 2027-01-31 (estimated)
Study Completion 2027-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-27