Long-Term Study on Safety and Performance of Global D Dental Implant Systems Including In-Kone UNIVERSAL, In-Kone PRIMO, twinKon, and EVL Series

What this Trial Is About

Researchers are evaluating the medium and long-term performance and safety of Global D dental implant-prosthetic systems. This observational study follows adult patients who had dental implant surgery using various Global D implant ranges, including In-Koneae UNIVERSAL, In-Koneae PRIMO, twinKonae, EVLae S, EVLae K, and EVLae C. The study is conducted under European Union regulations and aims to collect data up to 10 years after implantation to better understand outcomes over time. The study collects data retrospectively and prospectively from patients who received implant surgery using these specific implant-prosthetic systems during specified periods between 2013 and 2015. It involves twelve centers in France and one in Greece. Patients undergo annual follow-up visits at 5, 78, and 10 years after surgery or visits related to implant removal within 10 years. The study monitors implant survival rates, system stability, success rates, gum appearance, adverse events, complications, and oral health impact scores. Participants provide consent for data use and have their past and ongoing clinical data collected from medical records and follow-up visits. Researchers assess implant survival over 5 years as the primary outcome and evaluate other measures such as implant stability at multiple time points, gum condition, complications, and quality of life impacts. The study includes safety monitoring up to 10 years post-implantation, with total participation duration varying based on implantation date and follow-up visits.

Study Evaluating the Performance and Safety in the Medium and Long Term of Global D Implant-prosthetic Systems