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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

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Phase N/A

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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

26 January 2024

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FAQs

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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.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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