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

Starting soon · Not applicable

Conditions studied: Occlusion, Occlusal Splints, Occlusal Analysis, Comfort

In brief

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

Key facts

Study ID

NCT07720453

Run by

Radboud University Medical Center

People needed

30

Starts

2026-09-01

Expected to finish

2027-01-31

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects aged 18-45 years
• Subjects with an ASA physical status classification of I-III.
• Subjects with healthy complete dentitions (except for congenitally missing teeth (agenesis), extractions of wisdom teeth, or tooth extractions for the purpose of orthodontic treatment in the past)
• Subjects willing and able to participate in the study
• Subjects willing to provide written informed consent for their participation in the study

You may not qualify if…

• Subjects presenting with active dental disease, extensive restorations affecting the occlusion, or other oral conditions that may interfere with the assessment of the occlusal splints
• Subjects with a history of autoimmune disorders
• Subjects with known allergies to acrylic materials
• Subjects with severe allergies manifested by a history of anaphylaxis or those with severe, chronic allergies (e.g., asthma) and subjects with an active infection of any kind at the time of enrollment
• Subjects who are pregnant or lactating
• Subjects enrolled in another investigational clinical trial

Where it is running

• RadboudUMC — Nijmegen, Gelderland, Netherlands

Full record on ClinicalTrials.gov

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