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New dental material could save baby teeth without staining

NCT ID NCT04863222

Disease control Sponsor: Geisinger Clinic 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study compares two dental materials, MTA and Biodentine, used to treat deep cavities in baby teeth. Researchers want to see which one works better and causes less tooth discoloration. The study involves 646 children aged 2 to 12 who need treatment on at least two baby molars. Participants will be followed for three years to check success rates and any signs of infection.

What this could mean

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

Active substance
Biodentine and mineral trioxide aggregate (MTA) are dental materials used to treat cavities in baby teeth.
What this could lead to
If Biodentine works as well as MTA, it could become a cheaper, non-staining option for treating cavities in children's baby teeth.
What could go wrong
This is a phase 4 study, so the materials are already in use. However, results may not apply to all children, and long-term success is still being checked.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 646 people

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

Started

Nov 2021

Expected to finish

Dec 2026

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 12 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: * Male or female patients ages of 2 to ≤12 years. * Bilateral symptomatic or asymptomatic vital primary molars with caries approximating or into the pulp. * Patient who need a pulpotomy and/or indirect pulp cap treatments in two or more quadrants. * Parents of patients who can provide consent in English. * Patients who need treatment in an operating room setting at Geisinger. Exclusion Criteria: * Pre-operative radiographic or clinical symptoms associated with irreversible pulpitis or necrotic pulp. * Radiographs not displaying furcation region of the tooth. * Patients with cardiac conditions who need prophylaxis for infective Endocarditis. * Patients with any type of cancer in the past or present. * Non-restorable molars.

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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.

Indirect pulp cap Pulpotomy

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

  • Geisinger

    RECRUITING

    Danville, Pennsylvania, 17822, United States

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