Status:
NOT_YET_RECRUITING
Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
Lead Sponsor:
Septodont
Collaborating Sponsors:
Axonal-Biostatem
Conditions:
Dental Restoration, Permanent
Dental Restorations
Eligibility:
All Genders
2+ years
Brief 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 i...
Detailed Description
This clinical investigation is done according to the European Medical Device Regulation (MDR) 2017/745 and is considered as an observational, post-market clinical follow-up study with no additional in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 15 2036
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT06955429
Start Date
September 1 2025
End Date
July 15 2036
Last Update
May 25 2025
Active Locations (6)
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1
HCL Lyon
Lyon, France, 69002
2
Cabinet dentaire
Nantes, France, 44093
3
Cabinet dentaire
Paris, France, 75008
4
Hôpital Rotschild
Paris, France, 75012