Can a fully digital approach replace the wax bite in making night guards?

NCT ID NCT07720453

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 22, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This study tests whether occlusal splints (night guards) made using a fully digital workflow are as comfortable and effective as those made with a traditional wax bite registration. Healthy volunteers aged 18 to 45 will wear both types of splints overnight for three weeks each. The goal is to see if skipping the wax bite step can still produce a well-fitting, comfortable splint.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CAD/CAM occlusal splint fabricated using a virtual increase of the vertical dimension
What this could lead to
If the digital workflow proves as comfortable and effective, it could simplify and speed up splint fabrication, reducing the need for traditional wax bite registrations.
What could go wrong
This is a small, early-stage trial in healthy volunteers, so results may not apply to patients with dental conditions. Comfort is subjective, and the digital splint may require more adjustments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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Contacts and locations

Locations

  • RadboudUMC

    Nijmegen, Gelderland, 6525EX, Netherlands

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