Kraainem

This research aims to collect long-term data on the performance and safety of Biodentine17 XP, a dental biomaterial used for coronal restorative and endodontic treatments. The study is observational and prospective, conducted across multiple centers in France and Belgium, involving general dental surgeons experienced in restorative and endodontic care, including pediatric dentistry. It follows European Medical Device Regulation guidelines and focuses on patients receiving routine dental care involving Biodentine17 XP. Participants will receive dental restorative or endodontic treatments using Biodentine17 XP as part of their standard care. There are no additional invasive procedures beyond the usual treatment. The study follows patients for up to 10 years to assess the long-term clinical outcomes of Biodentine17 XP in both temporary teeth (with a 2-year follow-up) and permanent teeth (with follow-up up to 10 years). Data collection occurs during regular dental visits. During the study, participants will undergo evaluations based on clinical and radiographic criteria to determine the success of the Biodentine17 XP treatment. Researchers will monitor treatment effectiveness and safety over time, with follow-ups scheduled according to the tooth type and treatment indication. The study duration accommodates extended observation to capture long-term results, ensuring comprehensive data on the material's performance.