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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01631-40 | Registry Identifier | French ID-RCB |
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| Name | Class |
|---|---|
| EndoData | UNKNOWN |
| Recherche Clinique en Odontologie (ReCOL) | NETWORK |
| QualityStat | UNKNOWN |
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In this observational, retro-prospective, and multicenter PMCF clinical investigation, Biodentineâ„¢, an active dentine substitute for professional dental use only, is evaluated at 10 years post-treatment, in its endodontic indications as followed:
Evaluation is done through a 10-year post-treatment follow-up with collection of radiographic, clinical examination and safety data.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biodentine™ | Device | 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. |
| 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 Biodentineâ„¢:
| At 10 years post-treatment |
| 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 Biodentineâ„¢:
|
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Inclusion Criteria:
Exclusion Criteria:
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160 patients with a permanent tooth treated at least 1 year and no more than 5.5 years ago through an endodontic microsurgery using Biodentineâ„¢, all microsurgery including root end-filling, external or internal root resorption repair, root and furcation perforation repair, apexification, and revitalization procedure by means of revascularization.
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| Name | Affiliation | Role |
|---|---|---|
| Brigitte Grosgogeat, MD, PhD | CHU de Lyon, France | Study Director |
| Marie Georgelin Gurgel, MD | CHU de Toulouse, France | Principal Investigator |
| Anne-Margaux Collignon, MD | AP-HP, Hôpital Louis Mourier, Colombes, France | Principal Investigator |
| Alexis Gaudin, MD | CHU de Nantes, France | Principal Investigator |
| Cyril Villat, MD, PhD | HCL de Lyon, France | Principal Investigator |
| Marie-Paule Gellé, MD | CHU de Reims, France | Principal Investigator |
| Sandrine Dahan, MD | Private dental practice, Paris, France | Principal Investigator |
| Grégory Caron, MD | Private dental practice, Paris, France | Principal Investigator |
| Cauris Couvrechel, MD | Private dental practice, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, Hôpital Louis Mourier | Colombes | France | ||||
| HCL de Lyon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41207457 | Result | Guidez C, Couvrechel C, Grosgogeat B, Collignon AM. Long-term evaluation of calcium silicate-based cement in endodontic indications: Five-year results on effectiveness and safety. J Dent. 2026 Jan;164:106217. doi: 10.1016/j.jdent.2025.106217. Epub 2025 Nov 7. |
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| ID | Term |
|---|---|
| D019553 | Tooth, Nonvital |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| From treatment onset to 10 years post-treatment |
| Lyon |
| France |
| CHU de Nantes | Nantes | France |
| Private dental care office | Paris | France |
| CHU de Reims | Reims | France |
| CHU de Toulouse | Toulouse | France |