The first patient of a total of 62 have been treated in AddBIO AB's clinical study
After years of preparation and a large number of animal studies and human studies, all approval has been given to start a clinical study that will lead to an evaluation of the performance and safety of the company's first product, Zolidd One ExHex Dental. The results from the study will form the basis for a CE mark of AddBIO's bioactive dental implant.
The first individual has been treated today and the recruitment of patients will continue during the fall. The study entitled ‘A randomized, multicentre, double blind, parallel study to evaluate the performance and safety of the Zolidd One ExHex dental implant compared to uncoated One ExHex dental implant in subjects with partial edentulism’ will include a total of 62 patients.