Endodontically Treated Teeth
Conditions
Brief 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.
Interventions
DEVICEBiodentine™
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.
Sponsors
Septodont
EndoData
Recherche Clinique en Odontologie (ReCOL)
QualityStat
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and radiographic success of treatment | At 10 years post-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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events (AE) and device deficiencies | From treatment onset to 10 years post-treatment | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMarie Georgelin Gurgel, MD
CHU de Toulouse, France
STUDY_DIRECTORBrigitte Grosgogeat, MD, PhD
CHU de Lyon, France
PRINCIPAL_INVESTIGATORAnne-Margaux Collignon, MD
AP-HP, Hôpital Louis Mourier, Colombes, France
PRINCIPAL_INVESTIGATORAlexis Gaudin, MD
CHU de Nantes, France
PRINCIPAL_INVESTIGATORCyril Villat, MD, PhD
HCL de Lyon, France
PRINCIPAL_INVESTIGATORMarie-Paule Gellé, MD
CHU de Reims, France
PRINCIPAL_INVESTIGATORSandrine Dahan, MD
Private dental practice, Paris, France
PRINCIPAL_INVESTIGATORGrégory Caron, MD
Private dental practice, Paris, France
PRINCIPAL_INVESTIGATORCauris Couvrechel, MD
Private dental practice, Paris, France
Outcome results
None listed