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

Launched by SEPTODONT · Apr 25, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a dental material called Biodentine™ XP, which is used for treating teeth that need repairs or endodontic procedures (like root canals). The goal of the study is to gather more information about how safe and effective this material is over a long period, up to 10 years. The trial is not yet recruiting participants, but it aims to include children aged 2 and older, as well as adults, who require dental treatment with Biodentine™ XP.

To be eligible for the study, participants must have a temporary or permanent tooth that needs treatment with this material. Adults will need to provide consent, and if a child is involved, a parent or guardian must also agree. It's important to note that some people may not be able to participate, such as those with serious dental issues or medical conditions that could affect healing. Participants in the trial can expect regular check-ups to monitor the performance of the treatment over time, helping researchers understand how well Biodentine™ XP works in real-life dental situations.

Gender

ALL

Eligibility criteria

• 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.