NCT05247138

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 142 (estimated)
• Sponsor: Septodont · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Type	Name	Description
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.

Timeline

• Start date: 2022-02-18
• Primary completion: 2025-12-31
• Completion: 2029-07-01
• First posted: 2022-02-18
• Last updated: 2024-05-03

Locations

11 sites across 1 country: France

Regulatory

• FDA-regulated device study