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NCT Number: NCT05084742

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Endodontically Treated Teeth Dental Pulp Diseases Stomatognathic Diseases Tooth Diseases Tooth, Nonvital

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP, Hôpital Louis Mourier, Colombes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biodentine™

Device

Biodentine™ is a bioactive dentin substitute from the " Active Biosilicate Technology® " innovation.

Study participants were treated from 1 year to 5,5 years ago through an endodontic microsurgery using Biodentine™ used in its endodontic indications, i.e., root end-filling, external or internal root resorption repair, root and furcation perforation repair, apexification, and revitalization procedure by means of revascularization.

Primary outcomes

  1. Clinical and radiographic success of treatment

    Time frame: At 10 years post-treatment

    The proportion of patients with successfull treatment at 10 years post-surgery will be determined on clinical and radiographic success evidences for each endodontic indication of Biodentine™:

    • In root end-filling
    • In root resorption repair (internal, external)
    • In root and furcation perforation repair
    • In apexification
    • In revitalization procedure by means of revascularization

Secondary outcomes

  1. Number of Adverse Events (AE) and device deficiencies

    Time frame: From treatment onset to 10 years post-treatment

    Safety at 10 years post-surgery will be determined based on the cumulative numbers of Adverse Events (AE) and device deficiencies observed from treatment onset to 10 years post-treatment, for each endodontic indication of Biodentine™:

    • In root end-filling
    • In root resorption repair (internal, external)
    • In root and furcation perforation repair
    • In apexification
    • In revitalization procedure by means of revascularization

Sponsors and collaborators

Lead sponsor

Septodont

Industry

Collaborators

  • EndoData
  • QualityStat
  • Recherche Clinique en Odontologie (ReCOL)

Registry information

Official study title

Observational Clinical Trial, Prospective and Multicenter, Measuring the Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications

Important dates

Study start
2021
Primary completion
2024
Study completion
2033
First posted
Oct 20, 2021
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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