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| Name | Class |
|---|---|
| EndoData | UNKNOWN |
| Recherche Clinique en Odontologie (ReCOL) | NETWORK |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioRootTM RCS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and radiological performance impact of the endodontic treatment at 5 years. | The "success" and "failure" of the 5-year clinical and radiological performance impact of the endodontic treatment. | At 5 years post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and radiological performance impact of the endodontic treatment at 10 years. | The "success" and "failure" of the 10-year clinical and radiological performance impact of the endodontic treatment.
|
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Inclusion Criteria:
Exclusion Criteria:
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Patient in need of root canal treatment (or retreatment).
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| Name | Affiliation | Role |
|---|---|---|
| Brigitte Grosgogeat, MD, PhD | CHU de Lyon, France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet Dentaire | Levallois-Perret | Perret | 92300 | France | ||
| Cabinet dentaire |
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| At 10 years post treatment |
| Evaluation of the need of treatment or retreatment at 5 and 10 years. | "The "success" and "failure" of the endodontic treatment at 5 and 10 years according treatment or retreatment. | At 5 and 10 Years post treatment |
| Assessment of the "tooth functional retention" at 5 and 10 years. | The success and failure of the "tooth functional retention" at 5 and 10 years after Root Canal Treatment with BioRoot™ RCS. | At 5 and 10 Years post treatment |
| The technical characteristics of the sealer BioRootTM RCS at 5 and 10 years after Root Canal Treatment. | The technical characteristics of the sealer BioRootTM RCS at 5 and 10 years after Root Canal Treatment "Not resorbable once hardened", "Not retractable over the years" and "Radiopaque" will be evaluated in patients with retro-alveolar radiographs at the follow-up consultation (in parallel of the baseline consultation). The technical characteristics are defined as follows:
| At 5 and 10 Years post treatment |
| The ease of use and insertion of BioRootTM RCS in the canal. | The ease of use and insertion of BioRootTM RCS in the canal will be evaluated with the score obtained on the Visual Analog Scale: score from 0 (Not at all) to 10 (Certainly Yes). | At 5 years post treatment |
| The Investigator overall satisfaction of the experience with BioRootTM RCS. | The Investigator overall satisfaction of the experience with BioRootTM RCS will be evaluated at 5 and 10 years after Root Canal Obturation with the score obtained on the Visual Analog Scale: score from 0 (Not at all) to 10 (Certainly Yes). | At 5 and 10 Years post treatment |
| The post-obturation adverse device effects. | The post-obturation adverse device effects will be evaluated with the list of adverse events occurring between the date of the root canal filling and the 5-year visit and between the 5-year visit and the 10-year visit. | At baseline visit, 5 and 10 years post treatment |
| Dijon |
| 21000 |
| France |
| Cabinet Dentaire | Muizon | 51140 | France |
| Cabinet dentaire | Paris | 75006 | France |
| Cabinet dentaire | Paris | 75009 | France |
| Cabinet dentaire | Plérin | 22190 | France |
| Cabinet dentaire | Saint-Amand-sur-Sèvre | 79700 | France |
| Cabinet dentaire | Sézanne | 51120 | France |
| Cabinet Medical | Villiers-sur-Marne | 94350 | France |