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Clinical Trials in France / NCT05247138
Active, not recruiting Observational

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

NCT05247138 · tracked via the Priya Life Science France tracker
Sponsor
Septodont
Phase
Observational
Started
2022-02-18
Last updated
2026-05-06

Condition(s) studied

Root Canal Obturation

Investigational drug(s) / intervention(s)

BioRootTM RCS

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient, male or female, \> 18 years of age at the time of inclusion in the study. * Patient who had a non-surgical root canal treatment with BioRootTM RCS, in a context of an endodontic treatment, or retreatment, 5 years (± 6 months) ago. * All roots of the investigational teeth were treated with BioRootTM RCS. * Having a documented retro-alveolar radiography immediately after root canal obturation. * Patient affiliated or beneficiary of a social security system. * Patient has signed his/her informed consent form. Exclusion Criteria: * History of malignant tumors in the 5 years prior to the root canal treatment. * Non-stabilized systemic disease during the month prior to the root canal treatment (diabetes, hypertension, thyroid disorders, etc.). * Patient who developed a systemic pathology after the root canal treatment with BioRootTM RCS. * The Root canal treatment with BioRootTM RCS is on a wisdom tooth. * Tooth presenting an advanced periodontal disease (parodontal pocket ≥ 5mm or bone loss ≥ 50%).

Primary outcome measure(s)

  • Clinical and radiological performance impact of the endodontic treatment at 5 years. — At 5 years post treatment
    The "success" and "failure" of the 5-year clinical and radiological performance impact of the endodontic treatment.

Trial sites (9)

FacilityCityRegionStatus
Cabinet Dentaire Levallois-Perret Perret
Cabinet dentaire Dijon France
Cabinet Dentaire Muizon France
Cabinet dentaire Paris France
Cabinet dentaire Paris France
Cabinet dentaire Plérin France
Cabinet dentaire Saint-Amand-sur-Sèvre France
Cabinet dentaire Sézanne France
Cabinet Medical Villiers-sur-Marne 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
Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications Active, not recruiting
Tooth Retention After Root Canal Treatment With Endomethasone N Active, not recruiting
Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures Active, not recruiting

Other trials for the same condition

Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRoot™ RCS: a Randomized Controlled Trial 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 NCT05247138 on ClinicalTrials.gov ↗ ← All trials in France