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New dental material tracked for 10 years to see how well it holds up

NCT ID NCT06955429

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 275 people who receive a dental material called Biodentine XP for fillings or root canal work. Researchers will check for up to 10 years to see if the treatment stays safe and effective, looking for signs like pain, infection, or healing on X-rays. The goal is to confirm how well this material works in everyday dental care.

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 275 people

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

Started

Oct 2025

Expected to finish

Feb 2037

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

Eligible patients are any male and female, adult patients who have undergone one of the following dental treatments using Biodentine™XP respecting the medical device indications.

Ages

2 years and older

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: 1. Temporary tooth, from a child ≥ 2 years old, requiring dental restorative treatment with Biodentine™ XP, and/or, Permanent (mature or immature) tooth, from a child or an adult, requiring a dental restorative and/or an endodontic treatment with Biodentine™ XP. 2. Adult patient with a signed informed consent form; For the minor, if in age to understand, an assent is required, and at least one parent or legal representative must consent. 3. Only in France: Subject affiliated or benefiting from a social/health insurance system. Exclusion Criteria: 1. Patient with one or more documented contraindication to use Biodentine™ XP (Refer to IFU). 2. Inadequate expected tooth lifetime as estimated by the investigator: * For a Temporary tooth: high probability of tooth loss within 2 years after treatment with Biodentine™ XP. * For a permanent tooth: high probability of tooth loss within 10 years after treatment with Biodentine™ XP. 3. Patient with any systemic disease that may hinder the normal healing process and/or the follow-up. 4. Adult patient under legal protection measures or unable to express his/her consent, and individual deprived of liberty by judicial or administrative decision, as well as individual receiving psychiatric care. 5. Periodontitis (stage 3, 4 or stage 2 grade C). 6. Inability to comply with study procedures. 7. Participation in another interventional clinical investigation that can induce bias in the study results.

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As listed by the trial registrant

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

Dental restoration, permanent Dental restorations Endodontic treatment

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CHU Rennes

    RECRUITING

    Rennes, 35000, France

  • Cabinet dentaire

    RECRUITING

    Nantes, 44093, France

  • Cabinet dentaire

    RECRUITING

    Paris, 75008, France

  • HCL Lyon

    RECRUITING

    Lyon, 69002, France

  • Hôpital Pitié Salpêtrière

    RECRUITING

    Paris, 75013, France

  • Hôpital Rotschild

    RECRUITING

    Paris, 75012, France

  • Queen Astrid Dental Practice

    RECRUITING

    Kraainem, Belgium

  • UZ Leuven - University hospital

    RECRUITING

    Leuven, Belgium

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