Safety and effectiveness of maxillary
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Title: Safety and effectiveness of maxillary early loaded titanium implants with a novel nanostructured calcium-incorporated surface (Xpeed): 1-year results from a pilot multicenter randomised controlled trial.
Deparment of Biomaterials, the Sahlgrenska Academy at Götenburg University, Sweden. [email protected]
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: Sixty patients were randomised to receive either 1 to 6 calcium-incorporated or control titanium implants in the maxilla according to a parallel group design at 2 different centres. Implants were submerged and exposed at 3 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. One year after loading, no drop-outs and no prosthesis or implant failures occurred. There were no statistically significant differences between groups for complications (P = 0.61; difference in proportions = -0.27; 95% CI -0.71 to 0.18) and mean marginal bone level changes (P = 0.64; mean difference -0.04 mm; 95% CI -0.22 to 0.13).
CONCLUSIONS: Nanostructured calcium-incorporated titanium implants seem to be at least as effective and safe as conventional titanium implants.
Key words: calcium-incorporated titanium, early loading, randomised controlled trial, surface modification