Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications. (BIOD XP)

April 30, 2026 updated by: Septodont

Observational, Prospective, International and Multicenter Clinical Investigation Measuring the Longterm Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.

The aim of this present study is to collect additional data for the post-marketing follow-up of Biodentine™ XP and measure long-term (up to 10 years) performance and safety of the biomaterial in all its indications.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical investigation is done according to the European Medical Device Regulation (MDR) 2017/745 and is considered as an observational, post-market clinical follow-up study with no additional invasive and cumbersome procedures. Biodentine™ XP has been marketed in the US since 2022 and was launched in Europe in May 2023.

The aim of the study is to collect additional data for the post-marketing follow-up of Biodentine™ XP and measure long-term (up to 10 years) performance and safety of the biomaterial in its coronal restorative and endodontic dental indications.

The investigators participating in the clinical investigation will be general dental surgeron practitioners, with a great experience in restorative and endodontic indications or in pediatric dentistry, also users of Biodentine™.

This Clinical Investigation is an Observational, Prospective, and Multicenter study. This clinical investigation will take place in several investigational centres in France and Belgium.

This Clinical InvestigatioI is a prospective study: Patients will be treated with the study device (according to its CE-marked Instruction For Use), then followed up.

Study Type

Observational

Enrollment (Estimated)

275

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Kraainem, Belgium
        • Recruiting
        • Queen Astrid Dental Practice
      • Leuven, Belgium
        • Recruiting
        • UZ Leuven - University hospital
  • France
      • Lyon, France, 69002
        • Recruiting
        • HCL Lyon
      • Nantes, France, 44093
        • Recruiting
        • Cabinet dentaire
      • Paris, France, 75013
        • Recruiting
        • Hopital Pitie Salpetriere
      • Paris, France, 75008
        • Recruiting
        • Cabinet dentaire
      • Paris, France, 75012
        • Recruiting
        • Hôpital Rotschild
      • Rennes, France, 35000
        • Recruiting
        • Chu Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Temporary teeth treated in restorative treatment

For temporary teeth treated in restorative treatment arm, the following restoration indications will be found :

  • In the crown
  • Permanent dentine restoration (including under composites or Inlay/Onlay)
  • Enamel restoration for up to 6 months
  • Restoration of deep and/or large coronal carious lesions
  • Restoration of cervical or radicular lesions
  • On the pulp
  • Direct pulp capping
  • Indirect pulp capping
  • Pulpotomy for diagnosed symptoms of reversible pulpitis and irreversible pulpitis where bleeding is controlled within 5 minutes
Device: Dental restorative or endodontic treatment requiring Biodentine XP use
In this observational and prospective study, the patients are included since this intervention is schedulded as part of their routine care.
Permanent (mature or immature) teeth treated in restorative treatment.

For permanent (mature or immature) teeth treated in restorative treatment arm, the following restoration indications will be found :

  • In the crown
  • Permanent dentine restoration (including under composites or Inlay/Onlay)
  • Temporary dentine-enamel restoration (for up to six-months)
  • Restoration of deep and/or large coronal carious lesions
  • Restoration of cervical or radicular lesions
  • On the pulp
  • Direct pulp capping
  • Indirect pulp capping
  • Pulpotomy for diagnosed symptoms of reversible pulpitis and irreversible pulpitis where bleeding is controlled within 5 minutes
Device: Dental restorative or endodontic treatment requiring Biodentine XP use
In this observational and prospective study, the patients are included since this intervention is schedulded as part of their routine care.
Permanent (mature or immature teeth) treated in endodontic treatment.

For permanent (mature or immature) teeth treated in endodontic treatment arm, the following endodontic indications will be found :

For permanent teeth (immature or mature):

  • Repair of root perforations
  • Repair of furcation perforations
  • Repair of perforating internal resorption
  • Repair of external resorption
  • Root-end filling in endodontic surgery (retrograde filling)

For immature permanent teeth with necrotic pulp:

  • Apexification
  • Revitalization procedure relying on root canal revascularisation.
Device: Dental restorative or endodontic treatment requiring Biodentine XP use
In this observational and prospective study, the patients are included since this intervention is schedulded as part of their routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed
Time Frame: At 2 years post-treatment for temporary teeth (for radiography if required); • At 10 years post-treatment for permanent (mature or immature) teeth.

Crown and pulp (restoration) Clinical: No pain, no pulpal symptomatology, no abscesses, no swelling, fistula. Positive response to the pulp vitality electric test.

Radiographic : No radiolucency at the site of treatment & no wideining of desmodontal space (permanent tooth), Root canal development (permanent immature teeth).

Indications in the root (endodontic) except revitalization Clinical success: No pain, no inflammation, no abscesses, no swelling and/or fistula. Natural motion or mobility ≤ 1mm, Negative periodontal probing (≤ 4 mm) or positive periodontal probing (> 4 mm) Radiographic success: Absence or reduction of radiolucency at the site of treatment.

Indications in the root (endodontic) only for revitalization:

Clinical success: No pain, no abscesses, no swelling and/or fistula, Mobility inferior or equal to the initial situation.

Radiographic success: Absence or reduction of radiolucency at the site of treatment. Root canal development (for permanent immature teeth)
At 2 years post-treatment for temporary teeth (for radiography if required); • At 10 years post-treatment for permanent (mature or immature) teeth.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed
Time Frame: 6 months,1 year for temporary teeth; 6 months, 1 year, 2 years and 5 years for permanent (mature or immature) teeth.
Treatment success based on clinical and radiographic criteria identical to primary endpoint.
6 months,1 year for temporary teeth; 6 months, 1 year, 2 years and 5 years for permanent (mature or immature) teeth.
Dentin bridge formation presence (only in restorative indications)
Time Frame: At 6 months, 1 year, 2 years post treatment with Biodentine™ XP for temporary teeth (based on X-ray done if required). At 6 months, 1 year, 2 years, 5 years and 10 years post-treatment for permanent (mature or immature teeth)
Presence of a dentine bridge observed on the radiographic exam (only for restorative indication).
At 6 months, 1 year, 2 years post treatment with Biodentine™ XP for temporary teeth (based on X-ray done if required). At 6 months, 1 year, 2 years, 5 years and 10 years post-treatment for permanent (mature or immature teeth)
Safety parameters of Biodentine™ XP during the whole duration of the study including the incidence of treatment-emergent adverse events and device deficiencies.
Time Frame: From treatment onset to 10 years for permanent teeth and 2 years for temporary teeth.

Safety during the study, based on information collected at each visit:

Adverse events, only those at least possible related to Biodentine™ XP as judged by both sponsor and investigator: nature, number, severity, relationship with Biodentine™ XP and follow up.

Biodentine™ XP deficiency: nature, number, severity.
From treatment onset to 10 years for permanent teeth and 2 years for temporary teeth.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability parameters of Biodentine™ XP on the whole procedure, assessed by the dental surgeon practitioner immediately after use, will be evaluated using a questionnaire designed for dentists.
Time Frame: At the initiation of the study, at its 6-month, 1-year, 2-year, 3-year, 4-year anniversary and after inclusion of all patients in the study.
Usability of Biodentine™ XP (all patient subgroups): completion of usability questionnaire by dental surgeons after using Biodentine™ XP and user summary questionnaire (overall satisfaction, …).
At the initiation of the study, at its 6-month, 1-year, 2-year, 3-year, 4-year anniversary and after inclusion of all patients in the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Septodont

Collaborators

DOCAPOST
Axonal-Biostatem

Investigators

  • Principal Investigator: Dr Katia Jedeon, Hôpital Rotschild
  • Principal Investigator: Pr Marjorie Zanini, Hopital Pitie Salpetriere
  • Principal Investigator: Pr Marie-Agnès Gasqui De Saint Joachim, Hôpital HCL lyon
  • Principal Investigator: Dr Justine Le Clerc, CHRU Rennes
  • Principal Investigator: Dr Sandrine DAHAN, Cabinet dentaire
  • Principal Investigator: Dr. Alexis Gaudin, Nantes University Hospital
  • Principal Investigator: Pr Joseph Sabbagh, DDS, MSc, PhD, HDR, FICD, Queen Astrid Dental Practice
  • Principal Investigator: Pr. Simon Mariano PEDANO DE PIERO, DDS, PhD, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2025

Primary Completion (Estimated)

February 29, 2032

Study Completion (Estimated)

February 28, 2037

Study Registration Dates

First Submitted

April 25, 2025

First Submitted That Met QC Criteria

April 25, 2025

First Posted (Actual)

May 2, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BIOD-XP_2024_01
  • 2024-A01862-45 (Other Identifier: ANSM, BIOLOGICAL RESEARCH AND COLLECTIONS (BRC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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