Long-term performance and safety of Biodentine™ XP for coronal restorations and endodontic treatments

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.

This project will test whether Biodentine™ XP works well and stays safe for up to 10 years when used to repair and treat teeth in children and adults.

Quick facts

• Study type: Observational
• Enrollment: 275 (estimated)
• Ages: 2 Years and up
• Sex: All
• Sponsor: Septodont (industry)
• Locations: 8 sites (Kraainem and 7 other locations)
• Trial ID: NCT06955429 on ClinicalTrials.gov

What this trial studies

This is a prospective, observational, multicenter post‑market follow‑up collecting up to 10 years of clinical performance and safety data for Biodentine™ XP in coronal restorative and endodontic indications. Patients receive routine dental care with Biodentine™ XP according to the device's CE‑marked instructions for use, and no additional invasive procedures are required beyond standard treatment and follow‑up. Investigators are experienced general dental practitioners and pediatric dentists at centers in France and Belgium. Outcomes include treatment success, tooth survival, and device‑related adverse events in a real‑world setting.

Who should consider this trial

Good fit: Ideal candidates are children (age ≥2) and adults with temporary or permanent teeth needing coronal restorative or endodontic treatment where the clinician plans to use Biodentine™ XP.

Not a fit: Patients with documented contraindications to Biodentine™ XP, those whose treated tooth is unlikely to survive the required follow‑up period, or those with relevant uncontrolled systemic disease may not receive benefit from participation.

Why it matters

Potential benefit: If successful, the findings could confirm long-term durability and safety of Biodentine™ XP, giving dentists and patients greater confidence in its use for restorations and endodontic repairs.

How similar studies have performed: Prior clinical and post‑marketing reports on Biodentine formulations have shown favorable short‑to‑medium‑term outcomes, but long‑term prospective data up to 10 years remain limited.

Eligibility criteria

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.

Where this trial is running

Kraainem and 7 other locations

• Queen Astrid Dental Practice — Kraainem, Belgium (RECRUITING)
• UZ Leuven - University hospital — Leuven, Belgium (RECRUITING)
• HCL Lyon — Lyon, France (RECRUITING)
• Cabinet dentaire — Nantes, France (RECRUITING)
• Cabinet dentaire — Paris, France (RECRUITING)
• Hôpital Rotschild — Paris, France (RECRUITING)
• Hôpital Pitié Salpêtrière — Paris, France (RECRUITING)
• CHU Rennes — Rennes, France (RECRUITING)

Study contacts

• Principal investigator: Dr Katia Jedeon — Hôpital Rotschild
• Study coordinator: Clinical Operations Medical Affairs Department

Conditions: Dental Restoration, Permanent, Dental Restorations, Endodontic Treatment, Dentine restoration, Coronal carious lesions, Restoration of cervical lesion, Restoration of radicular lesion, Pulp capping