Clinical Performance of CAD/CAM Occlusal Splints Fabricated With or Without a Wax Bite Registration in Healthy Adults
Splint
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2026
CompletedFirst Posted
Study publicly available on registry
July 22, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
Study Completion
Last participant's last visit for all outcomes
January 31, 2027
July 27, 2026
July 1, 2026
5 months
July 17, 2026
July 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participant-reported comfort
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)
From enrollment to the end of treatment at 7 weeks
Study Arms (2)
Sequence B
EXPERIMENTALParticipants 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.
Sequence A
EXPERIMENTALParticipants 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.
Interventions
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).
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).
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
RadboudUMC
Nijmegen, Gelderland, 6525EX, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sabine Mechelse, MSc
Radboud University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2026
First Posted
July 22, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
July 27, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 3 years after the publication of results.
- Access Criteria
- To ensure confidentiality and compliance, access to IPD will be restricted to authorized personnel involved in the research process, including the Principal Investigator (PI), specific research team members, external collaborators, and regulatory authorities. Access is based on each individual's role and necessity for the research. The PI will have full access to the IPD, pseudonymized data, and supporting documents for data management and reporting. Research team members, such as co- investigators, assistants, and statisticians, will have access to the data necessary for their assigned tasks. Access will be controlled through formal data requests, Data Use Agreements, and secure platforms. Pseudonymization ensures participant confidentiality while enabling the sharing of valuable research data for scientific progress.
Specific IPD datasets, such as those underlying published results, will be shared. However, this sharing will occur under strict conditions to ensure data security and participant confidentiality. The data will be pseudonymized, using a secure key management system to separate identifiers from research data. Access will require appropriate agreements, ensuring compliance with ethical and legal standards, and will be granted only for research purposes aligning with the study's objectives.