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
Septodont
142 participants
Feb 18, 2022
OBSERVATIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria5
- 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%).
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Interventions
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)
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NCT05247138