Informations générales (source: ClinicalTrials.gov)
Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS: a Retro-prospective, National and Multicentre Clinical Study (BioRoot)
Observational
Septodont (Voir sur ClinicalTrials)
février 2022
juillet 2029
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CPEF LEVALLOIS PERRET | Virginie TOUBOUL, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Cabinet dentaire - 21000 - Dijon - France | Christopher DELBART, MD | Contact (sur clinicalTrials) | |||
| Cabinet dentaire - 22190 - Plerin - France | Adrien LE VERGE, MD | Contact (sur clinicalTrials) | |||
| Cabinet dentaire - 51120 - Sezanne - France | Xavier CATTEAU, MD | Contact (sur clinicalTrials) | |||
| Cabinet dentaire - 51120 - Sézanne - France | Nicolas CONDUTO, MD | Contact (sur clinicalTrials) | |||
| Cabinet Dentaire - 51140 - Muizon - France | Florence BONNET, MD | Contact (sur clinicalTrials) | |||
| Cabinet dentaire - 75006 - Paris - France | Cauris COUVRECHEL, MD | Contact (sur clinicalTrials) | |||
| Cabinet dentaire - 75009 - Paris - France | Katherine SEMINNIKOVA, MD | Contact (sur clinicalTrials) | |||
| Cabinet dentaire - 79700 - Saint-Amand-sur-Sèvre - France | Hélène CHIFFOLEAU, MD | Contact (sur clinicalTrials) | |||
| Cabinet Medical - 94350 - Villiers-sur-Marne - France | Nathalie JANISSET, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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%).