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

Last updated: November 28, 2023
Sponsor: Septodont
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Biodentine™

Clinical Study ID

NCT05084742
BIOD2021-03
2021-A01631-40
  • All Genders

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

  • Male or female, adult or child with permanent study tooth (immature or mature)
  • Study tooth treated with an endodontic microsurgery using Biodentine™: allmicrosurgery 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 tothe study

Exclusion

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 Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: Biodentine™
Phase:
Study Start date:
November 08, 2021
Estimated Completion Date:
September 30, 2031

Connect with a study center

  • AP-HP, Hôpital Louis Mourier

    Colombes,
    France

    Active - Recruiting

  • HCL de Lyon

    Lyon,
    France

    Active - Recruiting

  • CHU de Nantes

    Nantes,
    France

    Active - Recruiting

  • Private dental care office

    Paris,
    France

    Active - Recruiting

  • CHU de Reims

    Reims,
    France

    Active - Recruiting

  • CHU de Toulouse

    Toulouse,
    France

    Active - Recruiting

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