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New Tooth-Colored crowns challenge metal standard for Kids' cavities

NCT ID NCT07357402

Disease control Sponsor: PHAM LE ANH THY 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether a new tooth-colored crown (Bioflx) works as well as the standard metal crown for fixing severely decayed baby molars in children aged 4 to 10. Each child gets one of each type on opposite sides of the mouth, and researchers check durability, gum health, and how happy kids and parents are with the look and feel. The goal is to find a more natural-looking option that still protects the tooth and keeps the mouth healthy.

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 25 people

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

Started

Aug 2025

Expected to finish

Oct 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

4 to 10 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 with at least two carious primary molars located on both the right and left sides of the dental arch and indicated for crown placement * Children and their parents have ability to communicate in Vietnamese * Primary molars indicated for full-coverage crown restoration, including teeth with: * Multi-surface caries * Extensive caries or enamel-dentin defects * Interproximal caries * High risk of failure with other restorative materials * Teeth following pulpotomy or pulpectomy Exclusion Criteria: * Uncooperative children * Presence of psychiatric or neurological disorders affecting communication ability * Malocclusion (crossbite or scissors bite) * Having abnormal parafunctional habits * Teeth with root resorption exceeding one half of the root length

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Conditions

The condition(s) this trial relates to.

dental caries

As listed by the trial registrant

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

Severely decayed primary molars requiring full-coverage crowns

Contacts and locations

Locations

  • University of Medicine and Pharmacy at Ho Chi Minh City

    Ho Chi Minh City, 700000, Vietnam

  • University of Medicine and Pharmacy at Ho Chi Minh City

    Ho Chi Minh City, Vietnam