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.