New dental cements could save painful teeth from root canals
NCT ID NCT06802536
First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This study tests two calcium silicate-based dental cements, Biodentine and NeoPutty, for treating irreversible pulpitis (severe tooth nerve inflammation) in adults. Sixty participants with deep cavities and spontaneous pain will receive a single-session pulpotomy, where the inflamed pulp is removed and covered with one of the materials. The goal is to see if the tooth survives without needing a root canal, with follow-ups at 3, 6, and 12 months.
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 NeoPutty (calcium silicate-based dental cements)
- What this could lead to
- If successful, this could offer a simpler, tooth-saving alternative to root canal treatment for inflamed dental pulp.
- What could go wrong
- This is a small, early-phase trial with only 60 participants. The treatments may fail to relieve pain, requiring root canal therapy instead.
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
-
60 people
The number who actually took part.
- Started
-
Apr 2024
- Finished
-
Dec 2025
- 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
-
18 to 50 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 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: * • Patient age must be between 18-50 years * Must be able to give written informed consent * Must have systemic status (ASA 1) * Must have mature permanent molar or premolar (lower upper) * Must be symptomatic (spontaneous pain - mild to severe), extremely deep (D4) carious teeth * Must have pulp exposure in non-selective carious cleaning procedure * Must have vital response in cold test and electric pulp test * Must have no periodontal disease * Must have restorable teeth * Must have teeth without pulp necrosis, sinus tract or swelling/abscess * Must have bleeding time less than 10 minutes * Maximum two teeth in a patient must be included in the study (must be in different quadrants and must have at least 2 weeks between treatment periods) Exclusion Criteria: * Teeth with incomplete root development * Teeth without symptoms of irreversible pulpitis * Severely affected teeth that do not respond to pulp sensitivity tests * Teeth without signs of bleeding after exposure with the pulp chamber * Teeth with pulp chamber open to the oral environment * Teeth with periodontal pockets greater than 4 mm deep * Teeth with suspected cracks or crown fractures that may be responsible for pulp pathology * Teeth with uncontrolled bleeding * Medically risky patients will be excluded from the study.
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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
-
Firat University
Elâzığ, Elâzığ, 23119, Turkey (Türkiye)
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