About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Patient with one or more documented contraindication to use Biodentine™ XP (Refer to IFU).
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.
Trial design
Treatments tested in this trial
- Dental restorative or endodontic treatment requiring Biodentine XP use