Clinical Trial

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

Study acronym: BioRoot RCS
Active, Not Recruiting
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-02-08; most recent amendment 2026-04-30.
Status change: Recruiting → Active, Not Recruiting 2026-04-30
Trial Details
NCT Number NCT05247138
Lead Sponsor Septodont
Collaborators: EndoData, Recherche Clinique en Odontologie (ReCOL)
Conditions Root Canal Obturation
Enrollment 142 participants
Start Date 2022-02-18
Primary Completion 2025-11-07 (estimated)
Study Completion 2029-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-06