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

Recruitingn/aAges 2 Years - anyAllSeptodont
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Dental restorative or endodontic treatment requiring Biodentine XP use
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Where

8 sites
Queen Astrid Dental Practice
Kraainem, Belgium
UZ Leuven - University hospital
Leuven, Belgium
HCL Lyon
Lyon, France
Cabinet dentaire
Nantes, France
Cabinet dentaire
Paris, France
Hôpital Rotschild
Paris, France
Hôpital Pitié Salpêtrière
Paris, France
CHU Rennes
Rennes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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