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RECRUITING
NCT05084742

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

Sponsor: Septodont

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

160

Start Date

2021-11-08

Completion Date

2031-09

Last Updated

2023-11-29

Healthy Volunteers

No

Interventions

DEVICE

Biodentine™

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.

Locations (8)

AP-HP, Hôpital Louis Mourier

Colombes, France

HCL de Lyon

Lyon, France

CHU de Nantes

Nantes, France

Private dental care office

Paris, France

Private dental care office

Paris, France

Private dental care office

Paris, France

CHU de Reims

Reims, France

CHU de Toulouse

Toulouse, France