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

Last updated: May 2, 2024
Sponsor: Septodont
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

BioRootTM RCS

Clinical Study ID

NCT05247138
BIOR 2021-04
  • Ages > 18
  • All Genders

Study 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

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 contextof 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 canalobturation.
  • Patient affiliated or beneficiary of a social security system.
  • Patient has signed his/her informed consent form.

Exclusion

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 withBioRootTM 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

Total Participants: 142
Treatment Group(s): 1
Primary Treatment: BioRootTM RCS
Phase:
Study Start date:
February 18, 2022
Estimated Completion Date:
July 01, 2029

Connect with a study center

  • Cabinet Dentaire

    Levallois-Perret, Perret 92300
    France

    Active - Recruiting

  • Cabinet dentaire

    Dijon, 21000
    France

    Active - Recruiting

  • Cabinet Dentaire

    Muizon, 51140
    France

    Active - Recruiting

  • Cabinet dentaire

    Muizon, 51140
    France

    Active - Recruiting

  • Cabinet dentaire

    Paris, 75006
    France

    Active - Recruiting

  • Cabinet dentaire

    Plerin, 22190
    France

    Active - Recruiting

  • Cabinet dentaire

    Saint-Amand-sur-Sèvre, 79700
    France

    Active - Recruiting

  • Cabinet dentaire

    Sezanne, 51120
    France

    Active - Recruiting

  • Cabinet dentaire

    Sézanne, 51120
    France

    Site Not Available

  • Cabinet Medical

    Villiers-sur-Marne, 94350
    France

    Active - Recruiting

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