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Which filling material best saves Children's baby teeth?

NCT ID NCT07769697

Disease control Sponsor: Inonu University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial tests four different materials used in pulpotomy, a procedure that removes infected pulp from a decayed baby tooth to save it. About 140 children aged 4 to 9 with deep cavities in their primary molars will receive one of the four materials. Researchers will check the teeth at 3, 6, 9, and 12 months to see which material keeps the tooth healthy and pain-free, both clinically and on X-rays.

What this could mean

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

Active substance
Four pulpotomy materials: ferric sulfate, mineral trioxide aggregate (MTA), calcium-enriched mixture (CEM), and TheraCal PT, applied after removing the damaged pulp in primary molars.
What this could lead to
If one material proves more successful, it could become the preferred choice for saving decayed baby teeth, reducing pain and the need for early tooth loss.
What could go wrong
This is a mid-sized trial, and results may not apply to all children or tooth types. Some materials may cause tooth sensitivity or fail over time, leading to infection or extraction.

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

140 people

The number who actually took part.

Started

Oct 2021

Finished

Oct 2022

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 9 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: Patient-related criteria * Children aged 4-9 years. * Healthy children with no systemic disease. * No regular medication use. * No known allergy to the study materials. * Cooperative patients able to undergo dental treatment. * Written informed consent obtained from the parent or legal guardian. Tooth-related criteria * Restorable primary molars with deep carious lesions requiring pulpotomy. * Clinical signs and symptoms consistent with reversible pulpitis (no spontaneous, lingering, or nocturnal pain). * No tenderness to percussion or pathological mobility. * No swelling or sinus tract associated with the study tooth. * Hemostasis achieved within 5 minutes after coronal pulp amputation. * No radiographic evidence of internal or external root resorption, furcation or periapical radiolucency, periodontal ligament widening, or pulp calcification. * At least two-thirds of the root length remaining. Exclusion Criteria: * Failure to meet any of the inclusion criteria. * No pulp exposure or pulp exposure ≤1 mm after complete caries removal. * Persistent pain during caries removal despite adequate local anesthesia, suggestive of advanced pulpal inflammation. * Excessive pulpal bleeding that could not be controlled within 5 minutes. * Presence of purulent exudate from the pulp. * Loss of patient cooperation during treatment. * Withdrawal of parental consent or inability to attend follow-up visits.

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Conditions

The condition(s) this trial relates to.

dental caries exposure, dental pulp

As listed by the trial registrant

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

Dental caries Primary molar pulpotomy Primary teeth Pulp exposure, dental

Contacts and locations

Locations

  • Inonu University

    Battalgazi, Malatya, Turkey (Türkiye)

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