Status:
RECRUITING
Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS.
Lead Sponsor:
Septodont
Collaborating Sponsors:
EndoData
Recherche Clinique en Odontologie (ReCOL)
Conditions:
Root Canal Obturation
Eligibility:
All Genders
18+ years
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 RC...
Eligibility Criteria
Inclusion
- 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
- 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%).
Key Trial Info
Start Date :
February 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT05247138
Start Date
February 18 2022
End Date
July 1 2029
Last Update
May 3 2024
Active Locations (11)
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1
Cabinet Dentaire
Levallois-Perret, Perret, France, 92300
2
Cabinet dentaire
Dijon, France, 21000
3
Cabinet Dentaire
Muizon, France, 51140
4
Cabinet dentaire
Muizon, France, 51140