Long-term evaluation of root canal treatment with BioRootTM RCS

Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS: a Retro-prospective, National and Multicentre Clinical Study

This study is looking at how well the BioRootTM RCS sealer works for root canal treatments over the long term in patients who had the procedure done five years ago.

Quick facts

• Study type: Observational
• Enrollment: 142 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Septodont (Industry-sponsored)
• Locations: 11 sites (Levallois-Perret, Perret and 10 other locations)
• Trial ID: NCT05247138 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather long-term clinical and safety data on root canal obturation using BioRootTM RCS, focusing on patients who underwent treatment or retreatment five years ago. Participants will be followed up at intervals of 5 and 10 years post-treatment to assess clinical outcomes, radiographic data, and any adverse events. Data will be collected by dentists from the initial visit through the study's conclusion, providing insights into the performance of the BioRootTM RCS sealer over time.

Who should consider this trial

Good fit: Ideal candidates are patients over 18 years old who received non-surgical root canal treatment with BioRootTM RCS five years ago.

Not a fit: Patients with a history of malignant tumors in the past five years or those who had root canal treatment on wisdom teeth may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the long-term effectiveness and safety of BioRootTM RCS in root canal treatments.

How similar studies have performed: While this study focuses on a specific product, similar observational studies have shown success in evaluating long-term outcomes of dental treatments.

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%).

Where this trial is running

Levallois-Perret, Perret and 10 other locations

• Cabinet Dentaire — Levallois-Perret, Perret, France (Recruiting)
• Cabinet dentaire — Dijon, France (Recruiting)
• Cabinet Dentaire — Muizon, France (Recruiting)
• Cabinet dentaire — Muizon, France (Recruiting)
• Cabinet dentaire — Paris, France (Recruiting)
• Cabinet dentaire — Paris, France (Not_yet_recruiting)
• Cabinet dentaire — Plerin, France (Recruiting)
• Cabinet dentaire — Saint-Amand-sur-Sèvre, France (Recruiting)
• Cabinet dentaire — Sezanne, France (Recruiting)
• Cabinet dentaire — Sézanne, France (Not_yet_recruiting)
• Cabinet Medical — Villiers-sur-Marne, France (Recruiting)

Study contacts

• Study coordinator: Farid Benabdallah, MD

Conditions Root Canal Obturation; Root Canal Sealer; Endodontic Treatment