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.
Study Type
OBSERVATIONAL
Enrollment
160
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.
AP-HP, Hôpital Louis Mourier
Colombes, France
RECRUITINGHCL de Lyon
Lyon, France
RECRUITINGCHU de Nantes
Nantes, France
RECRUITINGPrivate dental care office
Paris, France
RECRUITINGPrivate dental care office
Paris, France
RECRUITINGPrivate dental care office
Paris, France
RECRUITINGCHU de Reims
Reims, France
RECRUITINGCHU de Toulouse
Toulouse, France
RECRUITINGClinical and radiographic success of treatment
The proportion of patients with successfull treatment at 10 years post-surgery will be determined on clinical and radiographic success evidences for each endodontic indication of Biodentine™: * In root end-filling * In root resorption repair (internal, external) * In root and furcation perforation repair * In apexification * In revitalization procedure by means of revascularization
Time frame: At 10 years post-treatment
Number of Adverse Events (AE) and device deficiencies
Safety at 10 years post-surgery will be determined based on the cumulative numbers of Adverse Events (AE) and device deficiencies observed from treatment onset to 10 years post-treatment, for each endodontic indication of Biodentine™: * In root end-filling * In root resorption repair (internal, external) * In root and furcation perforation repair * In apexification * In revitalization procedure by means of revascularization
Time frame: From treatment onset to 10 years post-treatment
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