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Could a Fluoride-Free toothpaste fix Kids' enamel defects?

NCT ID NCT07177053

Disease control Sponsor: Dubai Health 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares a fluoride-free hydroxyapatite toothpaste to standard fluoride toothpaste for repairing enamel in children aged 6-12 with Molar Incisor Hypomineralization (MIH), a condition causing weak, sensitive teeth. Over 12 months, researchers will measure changes in enamel fluorescence and lesion size using special imaging. The goal is to see if the hydroxyapatite toothpaste can effectively remineralize teeth while addressing parents' concerns about fluoride.

What this could mean

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

Active substance
hydroxyapatite toothpaste (KAREX KINDER) and fluoride toothpaste (Colgate Total PROTECTION ACTIVE)
What this could lead to
If it works, this could offer a fluoride-free alternative to help repair enamel and reduce sensitivity in children with Molar Incisor Hypomineralization.
What could go wrong
This is a Phase 2 trial with 160 children, so results are preliminary. The hydroxyapatite toothpaste may not be as effective as fluoride, and the study is open-label, which can introduce bias.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 160 people

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

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

6 to 12 years

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: * at least one affected permanent molar or incisor * good general health * parental informed consent, and the child's assent Exclusion Criteria: * Patients with systemic conditions affecting enamel or recent use of desensitizing treatments.

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Conditions

The condition(s) this trial relates to.

Molar Hypomineralization

As listed by the trial registrant

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

Molar incisor hypomineralisation

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.