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New tooth crowns for kids: a pretty alternative to metal?

NCT ID NCT07465211

Disease control Sponsor: satish vishwanathaiah 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared two types of dental crowns for children's baby molars: the standard stainless steel crown and a newer, tooth-colored BIOFLX crown. Researchers treated 36 children who had at least two decayed baby molars needing crowns. They checked the crowns after 1, 3, 6, and 12 months for things like fit, color, and any problems, and also asked parents how satisfied they were. The goal was to see if the more natural-looking BIOFLX crown could be a good alternative to the metal one.

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 (aesthetic metal-free crown) and Stainless Steel crown
What this could lead to
If BIOFLX crowns work as well as stainless steel crowns, they could offer a more natural-looking option for restoring decayed baby teeth in children.
What could go wrong
This is a very small study (36 children) and only looked at short-term results. The findings may not apply to all children or all types of tooth decay.

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

36 people

The number who actually took part.

Started

Jun 2025

Finished

Sep 2025

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

Up 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: * • At least two primary molars (contra-lateral or opposing side) needing full coverage restoration. * Consent of patient/legal guardian of the child * Cooperative behaviour based on Frankel behaviour rating 3 or 4 (positive or definitely positive) Exclusion Criteria: * • Parent not willing to give consent. * Child with special health care needs * Uncooperative child based on Frankel rating1or 2 (definitely negative or negative) * History of Ni-Cr allergy

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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.

Dental caries Restored decayed teeth and post-operative sensitivity

Contacts and locations

Locations

  • Mahatma Gandhi dental college and hospital

    Jaipur, Rajasthan, 302022, India

More trials for these conditions

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