New antibiotic paste could replace root canals in Kids' teeth
NCT ID NCT06811636
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.
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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
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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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Other studies related to the condition(s) this trial covers.
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