Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications
NCT ID: NCT05084742
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
160 participants
OBSERVATIONAL
2021-11-08
2031-09-30
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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EndoData
UNKNOWN
Recherche Clinique en Odontologie (ReCOL)
NETWORK
QualityStat
UNKNOWN
Septodont
INDUSTRY
Responsible Party
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Principal Investigators
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Brigitte Grosgogeat, MD, PhD
Role: STUDY_DIRECTOR
CHU de Lyon, France
Marie Georgelin Gurgel, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Toulouse, France
Anne-Margaux Collignon, MD
Role: PRINCIPAL_INVESTIGATOR
AP-HP, Hôpital Louis Mourier, Colombes, France
Alexis Gaudin, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Nantes, France
Cyril Villat, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
HCL de Lyon, France
Marie-Paule Gellé, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Reims, France
Sandrine Dahan, MD
Role: PRINCIPAL_INVESTIGATOR
Private dental practice, Paris, France
Grégory Caron, MD
Role: PRINCIPAL_INVESTIGATOR
Private dental practice, Paris, France
Cauris Couvrechel, MD
Role: PRINCIPAL_INVESTIGATOR
Private dental practice, Paris, France
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Anne-Margaux Collignon, MD
Role: primary
Cyril Villat, MD, PhD
Role: primary
Alexis Gaudin, MD
Role: primary
Sandrine Dahan, MD
Role: primary
Grégory Caron, MD
Role: primary
Cauris Couvrechel, MD
Role: primary
Marie-Paule Gellé, MD, PhD
Role: primary
Marie Georgelin Gurgel, MD
Role: primary
Other Identifiers
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2021-A01631-40
Identifier Type: REGISTRY
Identifier Source: secondary_id
BIOD2021-03
Identifier Type: -
Identifier Source: org_study_id