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5-Year dental filler study aims to prove its worth

NCT ID NCT05247138

Disease control Sponsor: Septodont Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how well a dental sealer called BioRoot RCS works for root canals over 5 and 10 years. Researchers will check 142 adults who had root canal treatment with this material 5 years ago. They will measure success by absence of pain, infection, and other signs of failure.

What this could mean

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

Active substance
BioRoot RCS (a dental sealer used with gutta-percha points to fill root canals)
What this could lead to
If successful, this could confirm that BioRoot RCS provides long-lasting, safe root canal fillings, reducing the need for retreatment.
What could go wrong
This is an observational follow-up study, not a new treatment test. Results may not apply to all patients, and some teeth may still fail over time.

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.

Participants

About 142 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patient in need of root canal treatment (or retreatment).

Ages

18 years and older

Sex

Anyone

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, male or female, \> 18 years of age at the time of inclusion in the study. * Patient who had a non-surgical root canal treatment with BioRootTM RCS, in a context of an endodontic treatment, or retreatment, 5 years (± 6 months) ago. * All roots of the investigational teeth were treated with BioRootTM RCS. * Having a documented retro-alveolar radiography immediately after root canal obturation. * Patient affiliated or beneficiary of a social security system. * Patient has signed his/her informed consent form. Exclusion Criteria: * History of malignant tumors in the 5 years prior to the root canal treatment. * Non-stabilized systemic disease during the month prior to the root canal treatment (diabetes, hypertension, thyroid disorders, etc.). * Patient who developed a systemic pathology after the root canal treatment with BioRootTM RCS. * The Root canal treatment with BioRootTM RCS is on a wisdom tooth. * Tooth presenting an advanced periodontal disease (parodontal pocket ≥ 5mm or bone loss ≥ 50%).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Root canal obturation

Contacts and locations

Locations

  • Cabinet Dentaire

    Levallois-Perret, Perret, 92300, France

  • Cabinet Dentaire

    Muizon, 51140, France

  • Cabinet Medical

    Villiers-sur-Marne, 94350, France

  • Cabinet dentaire

    Dijon, 21000, France

  • Cabinet dentaire

    Paris, 75006, France

  • Cabinet dentaire

    Paris, 75009, France

  • Cabinet dentaire

    Plérin, 22190, France

  • Cabinet dentaire

    Saint-Amand-sur-Sèvre, 79700, France

  • Cabinet dentaire

    Sézanne, 51120, France

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