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New dental cements could save painful teeth from root canals

NCT ID NCT06802536

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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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