Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With … (NCT05247138) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS.
France142 participantsStarted 2022-02-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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%).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical and radiological performance impact of the endodontic treatment at 5 years.