RecruitingNot Applicable

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

Belgium, France275 participantsStarted 2025-10-23

Plain-language 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.

Who can participate

Age range2 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. Patient with one or more documented contraindication to use Biodentine™ XP (Refer to IFU).
✕. Inadequate expected tooth lifetime as estimated by the investigator:
✕. 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.

What they're measuring

Success rate of the treatment with Biodentine™ XP based on clinical and radiographic criteria observed

Timeframe: At 2 years post-treatment for temporary teeth (for radiography if required); • At 10 years post-treatment for permanent (mature or immature) teeth.

Trial details

NCT IDNCT06955429

SponsorSeptodont

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2032-02-29

Contact for this trial

Clinical Operations Medical Affairs Department

1 49 76 70 00 clinical-operations@septodont.com

View on ClinicalTrials.gov More Dental Restoration, Permanent trials