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Search / Trial NCT05247138

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

Launched by SEPTODONT · Feb 8, 2022

Trial Information

Current as of June 06, 2025

Recruiting

Keywords

Root Canal Sealer Endodontic Treatment

ClinConnect Summary

This clinical trial is studying the long-term effectiveness and safety of a root canal treatment called BioRootTM RCS. It aims to follow patients who received this treatment about five years ago to see how well it has worked over time. Researchers will gather information about the patients' dental health, any side effects they may have experienced, and how the BioRootTM RCS material has performed during the study period.

To participate in this study, individuals must be at least 18 years old and have undergone a non-surgical root canal treatment using BioRootTM RCS within the last five years. Participants will have their dental health monitored at two points: five years and ten years after their initial treatment. This study is currently recruiting patients, and it’s important for those considering joining to know that certain medical histories may exclude them from participation. Overall, this trial seeks to provide valuable insights into the long-term success of BioRootTM RCS in treating root canal issues.

Gender

ALL

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%).

About Septodont

Septodont is a global leader in dental pharmaceuticals and medical devices, committed to enhancing patient care through innovative solutions. With a strong focus on research and development, Septodont specializes in products that improve dental practices and outcomes, including local anesthetics, analgesics, and restorative materials. The company prioritizes quality and safety in its clinical trials, ensuring that new therapies meet rigorous regulatory standards and address the evolving needs of dental professionals and their patients. Through its dedication to excellence and collaboration, Septodont aims to advance dental health worldwide.

Locations

Levallois Perret, Perret, France

Dijon, , France

Muizon, , France

Paris, , France

Plerin, , France

Saint Amand Sur Sèvre, , France

Sezanne, , France

Sézanne, , France

Villiers Sur Marne, , France

Patients applied

0 patients applied

Trial Officials

Brigitte Grosgogeat, MD, PhD

Study Director

CHU de Lyon, France

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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