MedTrace Logo

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

NCT07720453 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-27

No results posted yet for this 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

Conditions

  • Occlusion
  • Occlusal Splints
  • Occlusal Analysis
  • Comfort

Interventions

DEVICE

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).

DEVICE

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).

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Sabine Mechelse, MSc · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07720453 on ClinicalTrials.gov