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.
RCT Entities:
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.