Clinical trial NCT05247138: Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS.
Official title: Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS: a Retro-prospective, National and Multicentre Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Root Canal Obturation
Keywords: Root Canal Sealer
Endodontic Treatment
Lead sponsor: Septodont
Sponsor class: INDUSTRY
Collaborators: name: EndoData
name: Recherche Clinique en Odontologie (ReCOL)
First posted: 2022-02-18
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patient in need of root canal treatment (or retreatment).

Brief 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 criteria: 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.

Exclusion Criteria:

* 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%).

Primary outcomes:
measure: Clinical and radiological performance impact of the endodontic treatment at 5 years.
timeFrame: At 5 years post treatment
Secondary outcomes:
measure: Clinical and radiological performance impact of the endodontic treatment at 10 years.
timeFrame: At 10 years post treatment
measure: Evaluation of the need of treatment or retreatment at 5 and 10 years.
timeFrame: At 5 and 10 Years post treatment
measure: Assessment of the "tooth functional retention" at 5 and 10 years.
timeFrame: At 5 and 10 Years post treatment
measure: The technical characteristics of the sealer BioRootTM RCS at 5 and 10 years after Root Canal Treatment.
timeFrame: At 5 and 10 Years post treatment
measure: The ease of use and insertion of BioRootTM RCS in the canal.
timeFrame: At 5 years post treatment
measure: The Investigator overall satisfaction of the experience with BioRootTM RCS.
timeFrame: At 5 and 10 Years post treatment
measure: The post-obturation adverse device effects.
timeFrame: At baseline visit, 5 and 10 years post treatment
Other outcomes:
Locations:
city: Levallois-Perret
country: France
facility: Cabinet Dentaire
state: Perret
city: Dijon
country: France
facility: Cabinet dentaire
city: Muizon
country: France
facility: Cabinet Dentaire
city: Muizon
country: France
facility: Cabinet dentaire
city: Paris
country: France
facility: Cabinet dentaire
city: Paris
country: France
facility: Cabinet dentaire
city: Plerin
country: France
facility: Cabinet dentaire
city: Saint-Amand-sur-Sèvre
country: France
facility: Cabinet dentaire
city: Sezanne
country: France
facility: Cabinet dentaire
city: Sézanne
country: France
facility: Cabinet dentaire
city: Villiers-sur-Marne
country: France
facility: Cabinet Medical
Study officials:
affiliation: CHU de Lyon, France
name: Brigitte Grosgogeat, MD, PhD
role: STUDY_DIRECTOR
References: