Prospective Multicenter Study on the Safety and Effectiveness of DSP Dental Implant Systems Using Real-World Data

What this Trial Is About

Researchers are evaluating the safety and effectiveness of various DSP dental implant systems in patients with partial or total tooth loss. The study focuses on implants such as Standard Internal Hexagon HIS, Large Internal Hexagon HIL, Flexcone FC, Mini Flexcone FCM, and Morse Internal Hexagon HIM. This prospective observational study aims to collect real-world data to better understand implant performance and patient outcomes. Participants will undergo surgical procedures using one of the DSP implant systems under local anesthesia in healthy edentulous regions. The study does not involve additional or experimental surgical interventions beyond standard clinical practice. Following surgery, patients will be monitored over one year with data collected at five scheduled visits baseline, immediately after surgery T0, 90 days T90, 180 days T180, and 360 days T360. The study is expected to continue for about 24 months after the first patient is included. During the study, researchers will assess implant success rates six months after the procedure and monitor any adverse events related to the medical device or surgical procedure for up to two years. Data will be collected electronically using REDCap software, evaluating factors such as osseointegration, safety, and efficacy. The goal is to provide evidence regarding the implant systems performance and support their safe use in dental rehabilitation.

Safety and Effectiveness of DSP Dental Implant Systems: Prospective Study Multicenter Involving Real-world Data