Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
Recruiting now
Conditions studied: Dental Restoration, Permanent, Dental Restorations, Endodontic Treatment
In brief
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.
Key facts
- Study ID
- NCT06955429
- Run by
- Septodont
- People needed
- 275
- Starts
- 2025-10-23
- Expected to finish
- 2037-02-28
- Last updated by the study team
- 2026-05-06
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- 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.
- Only in France: Subject affiliated or benefiting from a social/health insurance system.
You may not qualify if…
- Patient with one or more documented contraindication to use Biodentine™ XP (Refer to IFU).
- 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.
- Patient with any systemic disease that may hinder the normal healing process and/or the follow-up.
- 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.
- Periodontitis (stage 3, 4 or stage 2 grade C).
- Inability to comply with study procedures.
- Participation in another interventional clinical investigation that can induce bias in the study results.
Where it is running
- Queen Astrid Dental Practice — Kraainem, Belgium (enrolling)
- UZ Leuven - University hospital — Leuven, Belgium (enrolling)
- HCL Lyon — Lyon, France (enrolling)
- Cabinet dentaire — Nantes, France (enrolling)
- Cabinet dentaire — Paris, France (enrolling)
- Hôpital Rotschild — Paris, France (enrolling)
- Hôpital Pitié Salpêtrière — Paris, France (enrolling)
- CHU Rennes — Rennes, France (enrolling)
Full record on ClinicalTrials.gov
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