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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorSeptodont

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

Treatment groups

275 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Septodont

Lead sponsor

DOCAPOST

Collaborator

Axonal-Biostatem

Collaborator