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RECRUITING
NCT05247138

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

Sponsor: Septodont

View on ClinicalTrials.gov

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.

Official title: Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS: a Retro-prospective, National and Multicentre Clinical Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

142

Start Date

2022-02-18

Completion Date

2029-07-01

Last Updated

2024-05-03

Healthy Volunteers

Not specified

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.

Locations (11)

Cabinet Dentaire

Levallois-Perret, Perret, France

Cabinet dentaire

Dijon, France

Cabinet Dentaire

Muizon, 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 dentaire

Sézanne, France

Cabinet Medical

Villiers-sur-Marne, France