Trial Status: Open
This clinical investigation, funded by the company Dentsply Sirona, is an open prospective, single-arm, multicenter, international Post-Market Clinical Follow-up investigation. The investigational product, OmniTaper EV implant, is available on the market and will be used according to approved instructions and manuals. All involved visits and procedures are according to normal dental practice and the clinical investigation include no additional invasive or burdensome procedures. In total 137 patients that are partly toothless, in need of an implant in the upper or lower jaw, and who fulfill the study requirements will be enrolled at approximately six sites in three countries (Germany, United Kingdom (Birmingham and Maidstone), and in Switzerland). The patient recruitment will be competitive. However, 20-25 patients are estimated to be enrolled at each site (40-50 patients in United Kingdom). The purpose of the study is to verify the safety and performance of the investigational product OmniTaper EV implant. The study consists of 11 standard visits. However, the implant surgery approach (e.g. one- or two-stage surgery) and time of dental prosthesis placement will be chosen by the study dentist depending on each patient’s dental situation. Depending on the chosen approach, the number of visits may be increased. In all cases, the final crown will be placed no later than 6 months after placement of the implant. After placement of the final crown each subject will be followed-up for five years.
The primary benefit for the patient is restoration of the chewing function. The primary objective of the study is to evaluate the number of implants in place one year after permanent restoration. In addition, outcomes such as implant success, oral conditions, complications and adverse events will be evaluated up to five years after permanent restoration. Examples of involved study procedures are oral examinations and radiographic examinations (X-Rays of the jaw).