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Can a new device catch tooth decay before it becomes a cavity?

NCT ID NCT07819370

Diagnosis Sponsor: Colgate Palmolive Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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.
Paused
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 Results may not be published yet.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)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing a device called BlueCheck to see if it can reliably find early enamel lesions and track how they change over 12 weeks. Participants aged 13 and older with active enamel lesions but no cavities needing immediate fillings receive high-fluoride toothpaste and have their teeth checked with BlueCheck, X-rays, and an intraoral camera. The goal is to learn whether BlueCheck gives consistent readings that could help dentists monitor early decay.

What this could mean

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

Active substance
BlueCheck, a device that detects early tooth decay, plus high-fluoride toothpaste
What this could lead to
If BlueCheck works, dentists could catch early enamel damage sooner and track whether fluoride toothpaste is repairing it, possibly heading off cavities before they need drilling.
What could go wrong
This is a tiny study with only five participants, so results may not hold up in larger groups. BlueCheck might miss lesions or give inconsistent readings, and it is not yet clear whether spotting lesions earlier actually changes outcomes.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 5 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

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

13 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Signed Informed Consent/Assent Form. * Male and female subjects aged 13 years or older. * Availability for the duration of the study. * Good general health and good oral health based on the opinion of the study investigator. * Subjects must have active enamel lesions and no cavities requiring immediate restoration in the mouth. * Subjects must be candidates for high fluoride toothpaste treatment. Exclusion Criteria: * Subjects with fixed or removable orthodontic appliances or removable partial dentures. * Obvious signs of periodontal disease or any condition that the dental examiner considers exclusionary from the study. * Cavities. * Concurrent participation in another oral clinical study. * Self-reported pregnant and/or lactating women, or those planning to become pregnant during the study. * History of allergies or sensitivity to personal care consumer products or their ingredients. * Medical condition which requires premedication prior to dental visits/procedure. * Significant oral soft tissue pathology, excluding plaque-induced gingivitis. * Dental prophylaxis within 30 days prior to study start. * Subjects who must receive dental treatment during the study dates. * Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy). * Use of smokeless tobacco, vaping, or e-cigarettes or suspected substance abuse. * Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1). * Subjects who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).

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Conditions

The condition(s) this trial relates to.

dental caries enamel caries

As listed by the trial registrant

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

Caries Enamel lesions

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Dental Dreams, LLC

    Lithonia, Georgia, 30038, United States

    Contact Email: •••••@•••••

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