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.
Study Type
OBSERVATIONAL
Enrollment
142
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.
Cabinet Dentaire
Levallois-Perret, Perret, France
RECRUITINGCabinet dentaire
Dijon, France
RECRUITINGCabinet Dentaire
Muizon, France
RECRUITINGCabinet dentaire
Muizon, France
RECRUITINGCabinet dentaire
Paris, France
RECRUITINGCabinet dentaire
Paris, France
NOT_YET_RECRUITINGCabinet dentaire
Plérin, France
RECRUITINGCabinet dentaire
Saint-Amand-sur-Sèvre, France
RECRUITINGCabinet dentaire
Sézanne, France
RECRUITINGCabinet dentaire
Sézanne, France
NOT_YET_RECRUITING...and 1 more locations
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.
Time frame: At 5 years post treatment
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. * Absence of pain * Absence of clinical evidence of infection, inflammation or swelling * Normal periodontal ligament space (PAI score ≤ 2) • "failure" of the endodontic treatment occur if the investigational tooth met one of the following criteria: * had been extracted for endodontic reasons since the root canal filling * Had been retreated since the root canal filling * Had undergone a periapical surgery since the root canal treatment * Presence of pain * Presence of clinical evidence of infection, inflammation or swelling * PAI score ≥ 3
Time frame: 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.
Time frame: 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.
Time frame: 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: * no resorption of the filling cement in the root, detectable on radiography * dense and homogeneous filling, limited to the canal * a filling with the maintenance of the canal anatomy
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: At baseline visit, 5 and 10 years post treatment
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