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Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.

NCT06955429 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 275

Last updated 2026-05-06

No results posted yet for this study

Summary

The aim of this present study is to collect additional data for the post-marketing follow-up of Biodentine™ XP and measure long-term (up to 10 years) performance and safety of the biomaterial in all its indications.

Conditions

  • Dental Restoration, Permanent
  • Dental Restorations
  • Endodontic Treatment

Interventions

DEVICE

Dental restorative or endodontic treatment requiring Biodentine XP use

In this observational and prospective study, the patients are included since this intervention is schedulded as part of their routine care.

Sponsors & Collaborators

  • DOCAPOST

    collaborator UNKNOWN

  • Axonal-Biostatem

    collaborator INDUSTRY

  • Septodont

    lead INDUSTRY

Principal Investigators

  • Dr Katia Jedeon · Hôpital Rotschild

  • Pr Marjorie Zanini · Hôpital Pitié Salpêtrière

  • Pr Marie-Agnès Gasqui De Saint Joachim · Hôpital HCL lyon

  • Dr. Alexis Gaudin · Nantes University Hospital

  • Dr Justine Le Clerc · CHRU Rennes

  • Dr Sandrine DAHAN · Cabinet dentaire

  • Pr Joseph Sabbagh, DDS, MSc, PhD, HDR, FICD · Queen Astrid Dental Practice

  • Pr. Simon Mariano PEDANO DE PIERO, DDS, PhD · UZ Leuven

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-23
Primary Completion
2032-02-29
Completion
2037-02-28
FDA Device
Yes

Countries

  • Belgium
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06955429 on ClinicalTrials.gov