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New white crowns for Kids' cavities could replace metal smiles

NCT ID NCT06713330

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study compares a new flexible white dental crown (BioFLX) to the standard stainless steel crown for treating cavities in baby molars. Researchers want to see if the white crown works just as well as the metal one in terms of gum health, plaque buildup, wear, and staying in place. The trial involves 50 children aged 2 to 5 who need crowns under general anesthesia.

What this could mean

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

Active substance
BioFLX crown (flexible white resin crown)
What this could lead to
If successful, this could offer a more natural-looking, metal-free option for dental crowns in children, potentially improving aesthetics and comfort.
What could go wrong
This is a small pilot study with only 50 children, so results may not apply to all kids. The new crown might wear faster or not stay in place as well as the metal version.

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 50 people

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

Started

May 2024

Expected to finish

Dec 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

2 to 5 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: * CCHMC pediatric dental patients between the ages of 2 years to 5 years and 11 months, at the time of recruitment, who present to any CCHMC dental clinic location and then are found to need full mouth dental rehabilitation. * Patients who speak the most common languages at CCHMC will be able to be recruited for the study. o English, Spanish, Arabic, Uzbek, Nepali, Chinese Mandarin, Russian, French. * These patients must qualify for treatment at the CCHMC dental in-office general anesthesia (IOGA) area or the Procedure Center (PC). IOGA and the PC will be selected as a venue of treatment to control behavioral factors. This is not specific to the study and would occur due to their treatment needs. * Participants will have at least one pair of contralateral primary molars with the need for a full coverage restoration in the same arch. * For example, tooth A \& J, B \& I, S \& L, or T \& K * For each participant, a minimum of one SSC or one PRC will be randomly assigned via a split mouth design to be placed as part of the study. * Need for Full coverage and high caries risk will be defined by AAPD Best Practice Guidelines 2,16 o Teeth With 1. Extensive caries 2. Cervical decalcification 3. Developmental defects (e.g., hypoplasia, hypocalcification) 4. When failure of other available restorative materials is likely (e.g., interproximal caries extending beyond line angles, patients with bruxism) 5. Following pulpotomy or pulpectomy 6. For definitive restorative treatment for high caries-risk children as defined by the AAPD 7. For patients who exhibit high caries risk and whose treatment is performed under sedation or general anesthesia. This would be normal and not specific to the study. * Participants who consent to the study, and who can be available for follow-up recall appointments. * All participants will be ASA I or ASA II as defined by the American Society of Anesthesiologists.15 Exclusion Criteria: * Participants who do not meet inclusion criteria will be excluded. * Participants whose teeth do not meet the inclusion criteria. * Participants who do not wish to participate in the study. * Patients who do not wish to or cannot reliably return for follow-up visits. * Red dye allergy as patient will not be able to be plaque disclosed during follow-up visits. * Participants who do not speak English, Spanish, Arabic, Uzbek, Nepali, Chinese Mandarin, Russian, French.

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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.

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

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

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