Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications

Launched by SEPTODONT · Oct 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the long-term performance and safety of a dental material called Biodentine™ used in various dental procedures for treated teeth over a period of 10 years. Biodentine™ is used in situations such as repairing holes in the root of a tooth, addressing conditions where the tooth structure has been lost (root resorptions), filling the end of a tooth during surgery, and helping teeth with open roots to heal. The goal is to see how well this material works and if there are any safety concerns over a decade after treatment.

To participate in this study, you need to be an adult or a child with a permanent tooth that has been treated using Biodentine™ for at least one year but not more than five and a half years ago. You should also have a baseline x-ray of your treated tooth and be willing to give your consent to join the study. Participants will undergo regular follow-ups that include clinical exams and x-rays to monitor the health of their treated teeth. This trial is currently looking for people to enroll, and it aims to provide valuable information on the long-term effects of this dental treatment.

Gender

ALL

Eligibility criteria

• 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