One-year results of a prospective multicenter study on Branemark System® implants with a TiUnite™ surface

Background: A moderately rough surface implant (TiUnite(TM), Nobel Biocare AB, Goteborg, Sweden) was introduced in 2000. Laboratory studies and some clinical studies have demonstrated excellent bone response in the early healing phase. Purpose: The aim of this prospective multicenter study was to follow a large number of consecutively treated patients using Branemark System(R) implants with the TiUnite surface. The current report constitutes the 1-year data of a planned 3-year study. Materials and Methods: Originally, the study comprised 43 surgeons from 22 centers in Sweden, Norway, and Finland. Five centers were excluded from the study because of poor compliance. Thus, 187 patients treated with 478 TiUnite implants were followed during I year of function. The majority of implants were inserted in maxillae (357 implants), and 78 of the implant sites were assigned the quality 4 figure. Radiographic evaluations were performed. Results: Five implants were lost up to and including the I-year follow-up, revealing implant cumulative survival rates of 98.6% and 100% for maxillae and mandibles, respectively. Three implants failed in quality 4 bone (3.8%). The mean marginal bone resorption at the end of the study period was 1.4 mm. The number of withdrawals of patients during the first year was high (19.3%). Conclusion: The present investigation showed a high implant cumulative survival rate of 98.9%. Values of marginal bone resorption were within normal ranges. No adverse effects of the TiUnite surface were reported, and complications during the study period were few and similar to those reported for the turned implant surface. However, the high number of excluded patients and the relatively high number of withdrawals must be observed and considered when interpreting data.