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

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.

Conditions

• Endodontically Treated Teeth

Interventions

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.

Sponsors & Collaborators

• EndoData

  collaborator UNKNOWN

• Recherche Clinique en Odontologie (ReCOL)

  collaborator NETWORK

• QualityStat

  collaborator UNKNOWN

• Septodont

  lead INDUSTRY

Principal Investigators

• Brigitte Grosgogeat, MD, PhD · CHU de Lyon, France

• Marie Georgelin Gurgel, MD · CHU de Toulouse, France

• Anne-Margaux Collignon, MD · AP-HP, Hôpital Louis Mourier, Colombes, France

• Alexis Gaudin, MD · CHU de Nantes, France

• Cyril Villat, MD, PhD · HCL de Lyon, France

• Marie-Paule Gellé, MD · CHU de Reims, France

• Sandrine Dahan, MD · Private dental practice, Paris, France

• Grégory Caron, MD · Private dental practice, Paris, France

• Cauris Couvrechel, MD · Private dental practice, Paris, France

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-08

Primary Completion

2024-04-23

Completion

2033-09-30

FDA Device

Yes

Countries

• France

Study Locations