Clinical Performance of CAD/CAM Occlusal Splints Fabricated With or Without a Wax Bite Registration in Healthy Adults | NCT07720453

NCT07720453

Overview

NCT ID: NCT07720453
Lead Sponsor: Radboud University Medical CenterOTHER
Official Title: Clinical Performance of CAD/CAM Occlusal Splints Fabricated With or Without Wax Bite Registration: A Randomized Crossover Clinical Trial
Brief 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
Conditions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Jan 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 30Estimated
Primary Purpose: Other
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Single

Contacts and Locations

Central Contacts: Sabine Mechelse, MScContact
sabine.mechelse@radboudumc.nl0031648136263

Similar Studies

Participant Group/Arms

Sequence BExperimental

Participants receive a CAD/CAM occlusal splint fabricated using a virtual increase of the vertical dimension (without a wax bite registration) for 3 weeks, followed by a CAD/CAM occlusal splint fabricated using a conventional wax bite registration for 3 weeks.

Device: Occlusal splint fabricated using a virtual increase of the vertical dimension

Device: Occlusal splint fabricated using a conventional wax bite registration

Sequence AExperimental

Participants receive a CAD/CAM occlusal splint fabricated using a conventional wax bite registration for 3 weeks, followed by a CAD/CAM occlusal splint fabricated using a virtual increase of the vertical dimension (without a wax bite registration) for 3 weeks.

Device: Occlusal splint fabricated using a virtual increase of the vertical dimension