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New antibiotic paste could replace root canals in Kids' teeth

NCT ID NCT06811636

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This study compares two treatments for infected baby molars in children aged 3 to 8: a less invasive method using a triple antibiotic paste versus a standard root canal with a calcium hydroxide-iodoform paste. The goal is to see which approach better relieves pain, swelling, and infection signs over time. Researchers will check both clinical symptoms and X-ray results to determine success.

What this could mean

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

Active substance
triple antibiotic paste and calcium hydroxide-iodoform paste
What this could lead to
If successful, this could offer a simpler, less invasive option for treating infected baby teeth in children, potentially avoiding the need for full root canals.
What could go wrong
This is a small, early-stage study with only 74 children, so results may not apply to everyone. The antibiotic paste might not fully clear the infection, and there is a risk of allergic reactions or tooth damage.

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

59 people

The number who actually took part.

Started

Apr 2025

Expected to finish

Dec 2028

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

3 to 8 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: * The participant is between the ages of 3 and 8 years. * The participant and their parent(s) have signed informed consent forms agreeing to participate in the study. * The patient is systemically healthy. * The patient's cooperation level is sufficient for performing the procedures. * No history of allergic reactions to the materials and substances to be used. * Mandibular primary molars diagnosed with pulp necrosis or irreversible pulpitis. * Presence of endodontic-origin gingival abscess or fistula in the involved teeth. * History of spontaneous pain. * Presence of radiolucency in the furcation or periapical region, not exceeding one-third of the affected area. * Presence of deep dentin caries causing pulp exposure. * Presence of mobility at level 0 or 1 according to Miller's classification (non-pathologic). * The tooth meets the criteria for restorability. * Root resorption does not exceed more than four-fifths of the root. * The tooth meets the criteria for isolation. Exclusion Criteria: * The participant is not between the ages of 3 and 8 years. * The participant and/or their parent(s) have not agreed to participate in the study or have not signed the informed consent forms. * The patient has a systemic disease. * The patient's cooperation level is insufficient to perform the procedures. * The patient has a history of allergic reactions to the materials and substances to be used. * Teeth with external or internal root resorption. * Mechanical or carious perforation of the pulp floor in the affected teeth. * Radiolucency and bone destruction in the furcation or periapical region exceeding one-third of the affected area. * Presence of caries that does not cause pulp exposure. * Pathological mobility according to Miller's classification (\>1 score). * The tooth does not meet the criteria for restorability. * Root resorption exceeds more than four-fifths of the root. * The tooth does not meet the criteria for isolation.

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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.

Contacts and locations

Locations

  • Canakkale Onsekiz Mart University

    Çanakkale, Kepez, 17100, Turkey (Türkiye)

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