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Clinical Trials in France / NCT05084742
Active, not recruiting Observational

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

NCT05084742 · tracked via the Priya Life Science France tracker
Sponsor
Septodont
Phase
Observational
Started
2021-11-08
Last updated
2026-05-06

Condition(s) studied

Endodontically Treated Teeth

Investigational drug(s) / intervention(s)

Biodentine™

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.

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
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

Primary outcome measure(s)

  • 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

Trial sites (6)

FacilityCityRegionStatus
AP-HP, Hôpital Louis Mourier Colombes France
HCL de Lyon Lyon France
CHU de Nantes Nantes France
Private dental care office Paris France
CHU de Reims Reims France
CHU de Toulouse Toulouse France

More Septodont trials in France

Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications. Recruiting
Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRoot™ RCS: a Randomized Controlled Trial Active, not recruiting
Tooth Retention After Root Canal Treatment With Endomethasone N Active, not recruiting
Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS. Active, not recruiting
Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05084742 on ClinicalTrials.gov ↗ ← All trials in France