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

NCT05247138 | Active Not Recruiting

• 1 other identifier: BIOR 2021-04
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 9

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.

Conditions

Root Canal Obturation

Keywords

Root Canal Sealer; Endodontic Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Clinical and radiological performance impact of the endodontic treatment at 10 years.

  At 10 years post treatment

• Evaluation of the need of treatment or retreatment at 5 and 10 years.

  At 5 and 10 Years post treatment

• Assessment of the "tooth functional retention" at 5 and 10 years.

  At 5 and 10 Years post treatment

• 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 ease of use and insertion of BioRootTM RCS in the canal.

  At 5 years post treatment

Interventions

BioRootTM RCS DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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%).

Sponsors & Collaborators

• Septodont: lead
• EndoData: collaborator
• Recherche Clinique en Odontologie (ReCOL): collaborator

Study Sites (9)

Cabinet Dentaire

Levallois-Perret, Perret, 92300, France

Location

Cabinet dentaire

Dijon, 21000, France

Location

Cabinet Dentaire

Muizon, 51140, France

Location

Cabinet dentaire

Paris, 75006, France

Location

Cabinet dentaire

Paris, 75009, France

Location

Cabinet dentaire

Plérin, 22190, France

Location

Cabinet dentaire

Saint-Amand-sur-Sèvre, 79700, France

Location

Cabinet dentaire

Sézanne, 51120, France

Location

Cabinet Medical

Villiers-sur-Marne, 94350, France

Location

Study Officials

• Brigitte Grosgogeat, MD, PhD

  CHU de Lyon, France

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: February 18, 2022
• Study Start: February 18, 2022
• Primary Completion: November 7, 2025
• Study Completion (Estimated): July 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)