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Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications
Sponsor: Septodont
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
Conditions
Interventions
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