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Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS.

NCT05247138 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 142

Last updated 2026-05-06

No results posted yet for this study

Summary

The aim of this retro-prospective Post-Market Clinical Follow-Up (PMCF) study is to collect long term clinical and safety data on root canal obturation after treatment, or retreatment, by BioRootTM RCS. The patients included in the study had received BioRootTM RCS 5 years ago. Participants will be followed prospectively at 5 and 10 years after root canal treatment.

Clinical data, radiographic data, adverse events (safety) and device performance will be collected by the dentist from the inclusion visit until the end of the study.

Conditions

  • Root Canal Obturation

Interventions

DEVICE

BioRootTM RCS

BioRoot™ RCS is a hydrophilic mineral root canal sealer prepared from the mixture of a powder part and a liquid part. BioRoot™ RCS is a class III implantable medical device. This device is intended to be used in dentistry for permanent obturation of root canals of permanent and mature teeth with adjunction of gutta-percha points. Exposure to the sealer BioRootTM RCS starts from the day when the root canal treatment is performed until the end of individual observational period or the removal of the sealer in case of extraction or retreatment, if this event occurs before the end of individual observational period.

Sponsors & Collaborators

  • EndoData

    collaborator UNKNOWN

  • Recherche Clinique en Odontologie (ReCOL)

    collaborator NETWORK

  • Septodont

    lead INDUSTRY

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-18
Primary Completion
2025-11-07
Completion
2029-07-01

Countries

  • 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 NCT05247138 on ClinicalTrials.gov