Long-Term Study on the Safety and Effectiveness of Biodentine XP for Dental Restorations and Root Canal Treatments in Children and Adults

What this Trial Is About

This research aims to collect long-term data over up to 10 years on the performance and safety of Biodentine17 XP, a dental biomaterial used in various coronal restorative and endodontic treatments. The study is observational and prospective, conducted in multiple centers in France and Belgium, involving general dental practitioners experienced in these treatments. It follows the European Medical Device Regulation MDR 2017745 and focuses on patients treated with Biodentine17 XP as part of routine care. Participants will receive treatment with Biodentine17 XP for temporary teeth requiring restorative care or permanent teeth needing restorative or endodontic treatments. Indications include restorations in crowns, dentine, enamel, pulp capping, pulpotomy, and various repairs in permanent teeth such as root perforations or apexification. Treatments are performed according to the devices approved instructions and no additional invasive procedures are introduced. During the study, participants will be monitored at multiple timepoints up to 10 years for permanent teeth and up to 2 years for temporary teeth. Evaluations include clinical and radiographic assessments of treatment success, dentin bridge formation, and safety monitoring for adverse events or device issues. The study measures success rates at intervals including 6 months, 1 year, 2 years, 5 years, and 10 years, with safety tracked throughout the entire follow-up period.

Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.