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Early loading of maxillary titanium implants with a nanostructured calcium-incorporated surface (Xpeed): 5-year results from a multicentre randomised controlled trial

Artikel i vetenskaplig tidskrift
Författare G. Gastaldi
M. G. Grusovin
P. Felice
C. Barausse
D. R. Ippolito
Marco Esposito
Publicerad i European Journal of Oral Implantology
Volym 10
Nummer/häfte 4
Sidor 415-424
ISSN 1756-2406
Publiceringsår 2017
Publicerad vid Institutionen för kliniska vetenskaper, Avdelningen för biomaterialvetenskap
Sidor 415-424
Språk en
Ämnesord calcium-incorporated titanium, early loading, randomised controlled trial, RBM surface, surface modification, 5 mm implants, longer implants, osseointegration, safety, Dentistry, Oral Surgery & Medicine
Ämneskategorier Biomaterialvetenskap

Sammanfattning

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.

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