Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS.

Recruiting

• Conditions: Root Canal Obturation

• Registration Number: NCT05247138
• Lead Sponsor: Septodont

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-28
• Study First Submitted QC: 2022-02-08
• Study Start: 2022-02-18
• Study First Posted: 2022-02-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03
• Primary Completion: 2025-12-31
• Study Completion: 2029-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 142

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%).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical and radiological performance impact of the endodontic treatment at 5 years.	At 5 years post treatment	The "success" and "failure" of the 5-year clinical and radiological performance impact of the endodontic treatment.

Secondary Outcome Measures

Name	Time	Method
The post-obturation adverse device effects.	At baseline visit, 5 and 10 years post treatment	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.
Clinical and radiological performance impact of the endodontic treatment at 10 years.	At 10 years post treatment	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
Evaluation of the need of treatment or retreatment at 5 and 10 years.	At 5 and 10 Years post treatment	"The "success" and "failure" of the endodontic treatment at 5 and 10 years according treatment or retreatment.
Assessment of the "tooth functional retention" at 5 and 10 years.	At 5 and 10 Years post treatment	The success and failure of the "tooth functional retention" at 5 and 10 years after Root Canal Treatment with BioRoot™ RCS.
The technical characteristics of the sealer BioRootTM RCS at 5 and 10 years after Root Canal Treatment.	At 5 and 10 Years post 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
The ease of use and insertion of BioRootTM RCS in the canal.	At 5 years post treatment	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).
The Investigator overall satisfaction of the experience with BioRootTM RCS.	At 5 and 10 Years post treatment	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).

Trial Locations

Locations (3)

Cabinet dentaire; 🇫🇷 Sézanne, France

Cabinet Dentaire; 🇫🇷 Muizon, France

Cabinet Medical; 🇫🇷 Villiers-sur-Marne, France