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Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS.
Sponsor: Septodont
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
Conditions
Interventions
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