Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications (NCT05084742) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications
France145 participantsStarted 2021-11-08
Plain-language summary
In this observational, retro-prospective, and multicenter PMCF clinical investigation, Biodentine™, an active dentine substitute for professional dental use only, is evaluated at 10 years post-treatment, in its endodontic indications as followed:
* Repair of root or furcation perforations.
* Repair of root resorptions (internal and external).
* Root-end filling in endodontic surgery (retrograde filling).
* Apexification (tooth with open apex).
* Revitalization procedure by means of revascularization.
Evaluation is done through a 10-year post-treatment follow-up with collection of radiographic, clinical examination and safety data.
Who can participate
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:
* Male or female, adult or child with permanent study tooth (immature or mature)
* Study tooth treated with an endodontic microsurgery using Biodentine™: all microsurgery including root end-filling, external or internal root resorption repair, root and furcation perforation repair and apexification
* Study tooth treated at least 1 year and no more than 5.5 years before inclusion visit
* Availability of baseline radiographic image of the study tooth
* Patient affiliated to national health insurance
* Patient informed about the study and who confirms his/her consent to participate to the study
Exclusion Criteria:
* Patient treated with anti-cancer therapy in the 5 years prior to the treatment
* Uncontrolled systemic disease 1 month prior to the treatment
* Development of a cancer or a systemic disease just after the treatment
* Participation to an interventional clinical trial at the time of the treatment
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.