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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Dr Katia Jedeon — Hôpital Rotschild
• Study coordinator: Clinical Operations Medical Affairs Department
• Email: clinical-operations@septodont.com
• Phone: 1 49 76 70 00

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Single-shade composite color match and satisfaction for injured upper front teeth

  This study will try a single-shade composite filling applied with an injection-molding technique to repair injured upper front permanent teeth in children aged 6–15 and see if the color matches, stays stable over 6 and 12 months, and if children and parents are satisfied.

  Recruiting Mahidol University · Bangkok · NCT07309653

• Comparing partial tooth restorations made with 3D printing versus CAD-CAM

  This project will try two types of partial tooth restorations—one 3D-printed and one made with CAD-CAM—in people who need restorations on two teeth to see which one performs better using FDI clinical criteria.

  Recruiting Cukurova University · Adana, Sarıçam · NCT07031856

• Does phosphoric acid etching time affect front-tooth composite fillings?

  We will test whether shortening phosphoric acid etching time changes how well direct composite fillings work for adults needing Class III or IV front-tooth restorations.

  Recruiting University Hospital, Basel, Switzerland · Basel, Canton of Basel-City · NCT06991842

• Assessing a new material for root canal treatment effectiveness

  This study is testing a new dental material called Endofill to see if it can make root canal treatments more effective and safe for adults aged 18 to 75.

  Recruiting Lumendo AG · Istanbul · NCT06312085

• Different endodontic motor motions during root canals and their effect on pain

  This study tests whether using different apical motion modes on endodontic motors during root canal work changes postoperative pain in adults with chronic apical periodontitis.

  Recruiting Alanya Alaaddin Keykubat University · Antalya · NCT07714733

• Effect of NiTi File Systems and XP-Endo Finisher on Postoperative Pain After Root Canal Treatment

  This study tests whether different NiTi file systems and the XP-Endo Finisher can reduce pain after endodontic treatment in adults.

  Recruiting at 2 sites Eskisehir Osmangazi University · Eskişehir, Odunpazarı and 1 other locations · NCT07642596

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.