Image

Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications

Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications

Not Recruiting
All
Phase N/A

Powered by AI

Overview

In this observational, retro-prospective, and multicenter PMCF clinical investigation, Biodentine™, an active dentine substitute for professional dental use only, is evaluated at 10 years post-treatment, in its endodontic indications as followed:

  • Repair of root or furcation perforations.
  • Repair of root resorptions (internal and external).
  • Root-end filling in endodontic surgery (retrograde filling).
  • Apexification (tooth with open apex).
  • Revitalization procedure by means of revascularization.

Evaluation is done through a 10-year post-treatment follow-up with collection of radiographic, clinical examination and safety data.

Eligibility

Inclusion Criteria:

  • Male or female, adult or child with permanent study tooth (immature or mature)
  • Study tooth treated with an endodontic microsurgery using Biodentine™: all microsurgery including root end-filling, external or internal root resorption repair, root and furcation perforation repair and apexification
  • Study tooth treated at least 1 year and no more than 5.5 years before inclusion visit
  • Availability of baseline radiographic image of the study tooth
  • Patient affiliated to national health insurance
  • Patient informed about the study and who confirms his/her consent to participate to the study

Exclusion Criteria:

  • Patient treated with anti-cancer therapy in the 5 years prior to the treatment
  • Uncontrolled systemic disease 1 month prior to the treatment
  • Development of a cancer or a systemic disease just after the treatment
  • Participation to an interventional clinical trial at the time of the treatment

Study details
    Endodontically Treated Teeth

NCT05084742

Septodont

13 May 2026

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.