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

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

Conditions
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Endodontically Treated Teeth

Intervention / Treatment
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* Device: Biodentine™


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical 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 | At 10 years post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From treatment onset to 10 years post-treatment |