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

November 28, 2023 updated by: Septodont

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Colombes, France
        • Recruiting
        • AP-HP, Hôpital Louis Mourier
        • Contact:
          • Anne-Margaux Collignon, MD
        • Principal Investigator:
          • Anne-Margaux Collignon, MD
        • Sub-Investigator:
          • Marie Sevin, MD
      • Lyon, France
        • Recruiting
        • HCL de Lyon
        • Contact:
          • Cyril Villat, MD, PhD
        • Principal Investigator:
          • Cyril Villat, MD, PhD
        • Sub-Investigator:
          • Raphaël Richert, MD
      • Nantes, France
        • Recruiting
        • CHU de Nantes
        • Contact:
          • Alexis Gaudin, MD
        • Principal Investigator:
          • Alexis Gaudin
      • Paris, France
        • Recruiting
        • Private dental care office
        • Contact:
          • Cauris Couvrechel, MD
        • Principal Investigator:
          • Cauris Couvrechel, MD
      • Reims, France
        • Recruiting
        • CHU de Reims
        • Contact:
          • Marie-Paule Gellé, MD, PhD
        • Principal Investigator:
          • Marie-Paule Gellé, MD, PhD
      • Toulouse, France
        • Recruiting
        • CHU de Toulouse
        • Contact:
          • Marie Georgelin Gurgel, MD
        • Principal Investigator:
          • Marie Georgelin Gurgel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

160 patients with a permanent tooth treated at least 1 year and no more than 5.5 years ago through an endodontic microsurgery using Biodentine™, 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical and radiographic success of treatment
Time Frame: 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
At 10 years post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Events (AE) and device deficiencies
Time Frame: 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
From treatment onset to 10 years post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Septodont

Collaborators

QualityStat
ReCOL
EndoData

Investigators

  • Principal Investigator: 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
  • Study Director: Brigitte Grosgogeat, MD, PhD, CHU de Lyon, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2021

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

September 1, 2031

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

October 6, 2021

First Posted (Actual)

October 20, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOD2021-03
  • 2021-A01631-40 (Registry Identifier: French ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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