Could a simple pulpotomy replace root canals for some patients?
NCT ID NCT04922229
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two treatments for irreversible pulpitis, a condition causing severe tooth pain. The standard treatment is a root canal, but researchers want to see if a less invasive procedure called pulpotomy works just as well. The study will involve 138 people and also look for biomarkers that predict success.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pulpotomy procedure
- What this could lead to
- If successful, this could show that a simpler, less invasive tooth-saving procedure works as well as a root canal for certain cases of severe tooth pain.
- What could go wrong
- This is a small, early-stage study that hasn't started yet. The pulpotomy may not be as effective long-term as the standard root canal, and results may not apply to all patients.
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
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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
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About 138 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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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
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12 to 99 years
- Sex
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Anyone
- Healthy volunteers
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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: * Maxillary or mandibular first or second mature permanent molars with carious lesions or restorations (excluding crowns), with signs and symptoms of symptomatic irreversible pulpitis (defined as spontaneous pulpal pain and cold hyperalgesia \>30 seconds), and normal apical tissues. * Tooth is responsive to cold and electrical pulp testing. * Patients aged ≥12 years for first molars and ≥16 years for second molars. Exclusion Criteria: * Evidence of Pulp Necrosis or Apical Periodontitis, preoperatively or upon inspection of an exposure site * Teeth that are badly broken down and/or are not restorable. * Teeth with mechanical allodynia assessed by registering bite force that is at least 50N lower than the contralateral side. * Teeth with radiographic evidence of internal, or external cervical, inflammatory or replacement root resorption, or with complete pulp canal obliteration. * Radiographic evidence of PDL space wider than three times normal width * Clinical evidence of swelling or sinus tract * Periodontal pocket probing depth ≥5 mm in any site around the tooth. * Clinical evidence of cracks connecting mesial and distal surfaces and/or extending in pulp chamber or associated with periodontal pockets ≥ 5 mm. * History of taking centrally acting drugs (e.g., tricyclic antidepressants), which interfere with the release of pain mediators and/or modify pain experience, within the previous 6 months. * Use of medications that affect the host response such as methotrexate, corticosteroids or cyclosporin. * Patients on immunosuppressive agents, chronic corticosteroid use, autoimmune disease, or other immunocompromising diseases or medications. * Patients who require IV sedation or general anesthesia for their dental treatment. * Teeth with full coverage crowns. * Teeth undergoing active orthodontic movement. * Teeth that require elective RCTx to place a post for restorative purposes. * Teeth with no contralateral molars with normal pulp and periapical tissues for bite and pulp testing controls. * Teeth in the pulpotomy group in which, following complete pulpotomy, bleeding does not stop after 10 minutes with 3-4% hypochlorite cotton pellet. These will be considered treatment failure and treated with RCTx.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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School of Dentistry, University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
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Other studies related to the condition(s) this trial covers.
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