Clinical Trial

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

Active, Not Recruiting
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-10-06; most recent amendment 2026-04-30.
Status change: Recruiting → Active, Not Recruiting 2026-04-30
Status change: Not Yet Recruiting → Recruiting 2021-11-10
Trial Details
NCT Number NCT05084742
Lead Sponsor Septodont
Collaborators: EndoData, Recherche Clinique en Odontologie (ReCOL), QualityStat
Conditions Endodontically Treated Teeth
Enrollment 145 participants
Start Date 2021-11-08
Primary Completion 2024-04-23 (estimated)
Study Completion 2033-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-06