Safety and effectiveness of early loaded maxillary titanium implants with a novel nanostructured calcium-incorporated surface (Xpeed): 3-year results from a pilot multicenter randomised controlled trial

Purpose: To evaluate clinical safety and effectiveness of a novel calcium-incorporated titanium implant surface (Xpeed, MegaGen Implant Co., Gyeongbuk, South Korea). Materials and methods: Sixty patients were randomised to receive one to six implants in the maxilla with either calcium-incorporated (Xpeed) or control resorbable blasted media (RBM) surfaces, according to a parallel group design at two centres. Implants were submerged and exposed at three different endpoints in equal groups of 20 patients, each at 12, 10 and 8 weeks, respectively. Within 2 weeks, implants were functionally loaded with provisional or definitive prostheses. Outcome measures were prosthesis failures, implant failures, any complications and peri-implant marginal bone level changes. Results: Thirty patients received 45 calcium-incorporated implants and 30 patients received 42 control titanium implants. Three years after loading four patients dropped-out from the Xpeed group and one from the RBM group. No prosthesis or implant failures occurred. There were no statistically significant differences between the groups for complications (P = 0.91; difference in proportions = 0.79 %; 95% CI -0.71 to 2.29) and mean marginal bone level changes (P = 0.88; mean difference = -0.02 mm; 95% CI -0.26 to 0.22). Conclusions: Both implant surfaces provided good clinical results and no significant difference was found when comparing titanium implants with a nanostructured calcium-incorporated surface versus implants with RBM surfaces. Conflict-of-interest statement: MegaGen partially supported this trial and donated the implants and prosthetic components. The study design was negotiated with MegaGen Implant Co. (Gyeongbuk, South Korea), however, data property belonged to the authors and by no means did MegaGen interfere with the conduct of the trial or the publication of its results.