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

NCT05084742 | Active Not Recruiting FDA Device

• 2 other identifiers: BIOD2021-032021-A01631-40
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 6

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.

Conditions

Endodontically Treated Teeth

Outcome Measures

Primary Outcomes (1)

• 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 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 Outcomes (1)

• Number of Adverse Events (AE) and device deficiencies

  From treatment onset to 10 years post-treatment

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Septodont: lead
• EndoData: collaborator
• Recherche Clinique en Odontologie (ReCOL): collaborator
• QualityStat: collaborator

Study Sites (6)

AP-HP, Hôpital Louis Mourier

Colombes, France

Location

HCL de Lyon

Lyon, France

Location

CHU de Nantes

Nantes, France

Location

Private dental care office

Paris, France

Location

CHU de Reims

Reims, France

Location

CHU de Toulouse

Toulouse, France

Location

Related Publications (1)

• 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.

  PMID: 41207457 RESULT

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 20, 2021
• Study Start: November 8, 2021
• Primary Completion: April 23, 2024
• Study Completion (Estimated): September 1, 2033
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)