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Fluoride-Free toothpaste could be just as good at stopping cavities

NCT ID NCT07068204

Prevention Sponsor: Dr. Joachim Enax Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a toothpaste made with 2% calcium hypophosphite to a standard fluoride toothpaste (1450 ppm F) to see if it can prevent cavities in adults. Over 18 months, 164 healthy adults will brush twice daily with one of the two toothpastes. The goal is to prove the new toothpaste is not worse than fluoride at keeping teeth cavity-free.

What this could mean

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

Active substance
2% calcium hypophosphite toothpaste
What this could lead to
If it works, this could offer an alternative cavity-preventing toothpaste for people who cannot or prefer not to use fluoride.
What could go wrong
This is a non-inferiority trial, meaning it only aims to show the new toothpaste is not worse than fluoride—not that it is better. The study is relatively small (164 adults) and results may not apply to everyone, such as those with existing cavities.

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 164 people

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

Started

Jan 2026

Expected to finish

Jan 2028

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

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: * A minimum of 10 healthy molars and premolars (DMFS of these teeth = 0) * Willingness to use an electric (powered) toothbrush * Willingness to use interdental floss * Willingness to have bitewing radiographs taken * Willingness to undergo an oral examination by an intraoral camera (DIAGNOcam) Exclusion Criteria: * Untreated caries \[clinical investigation and analysis with an intraoral camera (DIAGNOcam)\] (→ unsuitable subjects with one or two untreated caries in need of a restoration can become eligible after restorative therapy. If there are three or more untreated caries patients will be excluded) * Xerostomia (medication, radiation, disease induced) * Chemo/radiation therapy * Physical or mental disability which prevents proper oral health care * Orthodontic treatment * Severe periodontitis at the Baseline Visit (pocket depth on at least one tooth ≥ 5.5 mm) * Known hypersensitivity to one of the ingredients of the toothpastes to be tested * Regular medication intake interfering with salivary function or flow * Current pregnancy, the wish to become pregnant, the suspicion of being pregnant, or breastfeeding or in the course of the study * 3 or more carious lesions/restorations in last 36 months until Baseline Visit * Teeth missing due to caries in last 36 months until Baseline Visit

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Conditions

The condition(s) this trial relates to.

dental caries prevention target

As listed by the trial registrant

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

Calcium hypophosphite Caries,dental Fluoridation

How to take part

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

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Department of Integrated Dentistry Medical University of Białystok

    NOT_YET_RECRUITING

    Bialystok, Poland, 15-276, Poland

  • Poznan University of Medical Sciences, Department of Integrated Dentistry

    RECRUITING

    Poznan, Poland, 60-812, Poland

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