Can a special varnish erase white spots left by braces?

NCT ID NCT04528134

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests two types of fluoride varnish—one that hardens with a special light and a standard one—to see if they can reverse white spot lesions (early cavities) that often appear after braces are removed. About 38 teenagers who are finishing orthodontic treatment will receive different varnishes on each side of their mouth, and researchers will track changes in the spots and in mouth bacteria over six months. The goal is to find a simple treatment that helps teeth heal and prevents cavities.

What this could mean

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

Active substance
fluoride varnish (light-cured resin-modified glass ionomer and 5% sodium fluoride)
What this could lead to
If effective, these varnishes could offer a simple, in-office way to reverse white spots after braces and reduce cavity risk.
What could go wrong
This is a small, early-stage trial with only 38 participants, so results may not apply broadly. The varnishes may not outperform placebo or standard care.

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

38 people

The number who actually took part.

Started

Feb 2022

Finished

Jul 2025

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

12 to 27 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: * Males and females, 12-17 years of age, inclusive, at the time the Assent and Informed Consent Form is signed * Systemically healthy, as determined by the investigator (in consultation with the Medical Monitor, as needed), based on medical history, concurrent illnesses, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (extraoral, head and neck) during screening * Is approaching the end of their orthodontic treatment using metal fixed oral appliances (brackets) on at least the maxillary arch * Subject has at least two visible white spot lesions at the time of recruitment on teeth treated with fixed oral appliances * Subject is willing to use only oral care products that fall within the standard of care (manual toothbrush and sodium fluoride toothpaste) for the duration of the study. * Subject is willing to postpone dental cleanings between the baseline and final visit (since subjects will receive cleanings 6 months apart at both the baseline and final visit, the standard of care will be maintained). * Subject is willing and able to comply with oral hygiene and diet instructions. * Subject is able to understand and sign the Assent and/or Informed Consent Form prior to initiation of study procedures * Subject is able to communicate with the Investigator/study personnel, understand and comply with the study requirements, and is willing to return for protocol-specified visits at the appointed times. Exclusion Criteria: * Advanced periodontal disease * Medical condition (e.g. artificial heart valve, history of infective endocarditis, cardiac transplant with valvular dysfunction, congenital heart disease or total joint replacement) for which antibiotics are recommended prior to dental visits and/or procedures * Pathologic lesions of the oral cavity (suspected or confirmed) * Use of systemic antibiotics, topical oral antibiotics, or use of other drugs, which in the opinion of the investigators could influence the study outcome, within 30 days prior to screening. * Presence of any condition or concurrent illness, which in the opinion of the investigators, would compromise normal immune function ((e.g., diabetes, rheumatoid arthritis, lupus, liver disease, organ transplant, etc.), interfere with the use of study dentifrice and oral care products, or interfere with the ability to comply with study requirements, or jeopardize the safety of the subject or the validity of the study results * Presence of xerostomia (dry mouth).

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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.

Contacts and locations

Locations

  • UCLA School of Dentistry

    Los Angeles, California, 90095, United States

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