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

NCT07720453 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Radboud University Medical Center

Phase

Not applicable

Started

2026-09-01

Last updated

2026-07-27

Condition(s) studied

OcclusionOcclusal SplintsOcclusal AnalysisComfort

Investigational drug(s) / intervention(s)

Occlusal splint fabricated using a virtual increase of the vertical dimensionOcclusal splint fabricated using a conventional wax bite registration

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).

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

45 Years

Healthy volunteers

Accepted

Inclusion criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Participant-reported comfort — From enrollment to the end of treatment at 7 weeks
Self-reported wear comfort by filling in a questionnaire. This scale measures the comfort of the occlusal splint (0-10), where "very uncomfortable" represents the worst experience (lowest score) and "very comfortable" represents the best experience (highest score). Minimum Value: very uncomfortable, Maximum Value: very comfortable. Higher Scores Mean: better comfort (more comfort)

Trial sites (1)

Facility	City	Region	Status
RadboudUMC	Nijmegen	Gelderland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07720453 on ClinicalTrials.gov ↗ ← All trials in the Netherlands