RecruitingNCT05084742

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

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

Sponsor

Septodont

Enrollment

160 participants

Start Date

Nov 8, 2021

Study Type

OBSERVATIONAL

Conditions

Endodontically Treated Teeth

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

Inclusion Criteria6

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 Criteria4

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

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Interventions

DEVICEBiodentine™

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.