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

Septodont

Status: Enrolling

Conditions: Endodontically Treated Teeth

Treatments: Device: Biodentine™

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05084742

2021-A01631-40 (Registry Identifier)

BIOD2021-03

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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