Purpose: To evaluate clinical safety and effectiveness of a novel calcium-incorporated titanium implant (Xpeed, MegaGen Implant Co. Limited, Gyeongbuk, South Korea). Materials and methods: In total, 60 patients were randomised to receive one to six titanium 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 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: A total of 30 patients received 45 calcium-incorporated implants and 30 patients were given 42 control titanium implants. Five years after loading, eight patients dropped-out from the Xpeed group and nine left the RBM group. No prosthesis or implant failures occurred. Two patients were affected by three complications in the Xpeed group vs five patients from the RBM group, who experienced eight complications; the difference between groups being not statistically significant different (P = 0.187; difference in proportions = 14.7%; 95% CI: -10.7% to 39.4%). Five years after loading patients with Xpeed implants lost on average 1.19 ± 0.48 mm of peri-implant marginal bone vs 1.43 ± 0.98 mm of patients with RBM implants, the difference being not statistically significant (P = 0.35; mean difference: -0.23 mm; 95% CI: -0.73 to 0.27 mm). Conclusions: Both implant surfaces provided good clinical results and no significant difference was found when comparing titanium implants with a nanostructured calcium-incorporated surface with implants with an RBM surface.
Parole chiave: calcium-incorporated titanium, early loading, randomised controlled trial, RBM surface, surface modification
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.
