Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
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.
Septodont
275 participants
Oct 23, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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.
Exclusion Criteria9
- 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.
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Interventions
In this observational and prospective study, the patients are included since this intervention is schedulded as part of their routine care.
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT06955429