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Ozone treatment may zap early cavities without the drill

NCT ID NCT07671651

Disease control Sponsor: Neslihan Atmaca 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This study tests whether ozone therapy, followed by a remineralizing gel, can reverse the earliest stage of cavities in children aged 6-14. Half of the 80 participants will get ozone plus gel, the other half just gel. Researchers will check the teeth over 8 weeks using special lights and lasers to see if the ozone helps heal the enamel.

What this could mean

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

Active substance
ozone therapy (device) plus remineralizing gel
What this could lead to
If it works, this could offer a simple, non-invasive way to reverse early cavities in children without drilling.
What could go wrong
This is a small, early-stage trial with only 80 children. The results may not apply to all kids or to more advanced 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 80 people

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

Started

Jun 2026

Expected to finish

Apr 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

6 to 14 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 Children aged 6-12 years. Presence of at least one initial non-cavitated caries lesion. Systemically healthy children. Frankl Behavior Rating Scale score of 3 or 4. Written informed consent obtained from the parent or legal guardian. Exclusion Criteria Cavitated caries lesions requiring restorative treatment. History of allergy to any study material. Systemic diseases affecting oral health or salivary flow. Respiratory diseases (e.g., asthma) contraindicating ozone therapy. Use of medications affecting salivary flow or enamel remineralization. Uncooperative children (Frankl score 1 or 2). Parent or guardian unwilling to participate or unable to attend follow-up visits.

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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.

Dental caries Early caries lesion

How to take part

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

  1. The places running it

    1 site. 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

  • Marmara Universty School of Dentistry

    RECRUITING

    Istanbul, Maltepe, 34854, Turkey (Türkiye)

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