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

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 Overview

• Status: Active, not recruiting
• Conditions: Root Canal Obturation
• Intervention / Treatment: Device: BioRootTM RCS

• Study Type: Observational
• Enrollment (Estimated): 142

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Cabinet dentaire
  • Muizon, France, 51140
    • Cabinet dentaire
  • Paris, France, 75006
    • Cabinet dentaire
  • Paris, France, 75009
    • Cabinet dentaire
  • Plérin, France, 22190
    • Cabinet dentaire
  • Saint-Amand-sur-Sèvre, France, 79700
    • Cabinet dentaire
  • Sézanne, France, 51120
    • Cabinet dentaire
  • Villiers-sur-Marne, France, 94350
    • Cabinet Medical
  • Perret
    • Levallois-Perret, Perret, France, 92300
      • Cabinet dentaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patient in need of root canal treatment (or retreatment).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.; 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	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: 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	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

Collaborators and Investigators

• Sponsor: Septodont
• Collaborators: EndoData; Recherche Clinique en Odontologie (ReCOL)
• Investigators: Study Director: Brigitte Grosgogeat, MD, PhD, CHU de Lyon, France

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Actual): November 7, 2025
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Root Canal Sealer; Endodontic Treatment
• Other Study ID Numbers: BIOR 2021-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No