Clinical Performance of CAD/CAM Occlusal Splints Fabricated With or Without a Wax Bite Registrati… (NCT07720453) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Performance of CAD/CAM Occlusal Splints Fabricated With or Without a Wax Bite Registration in Healthy Adults
Netherlands30 participantsStarted 2026-09-01
Plain-language 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
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participant-reported comfort
Timeframe: From enrollment to the end of treatment at 7 weeks