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.
OBJECTIVE
To evaluate clinical safety and effectiveness of a novel calcium-incorporated titanium implant surface (Xpeed, MegaGen Implant Co., Gyeongbuk, South Korea).


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.
Pietro
P
Felice
Maria Gabriella
MG
Grusovin
Carlo
C
Barausse
Giovanni
G
Grandi
Marco
M
Esposito
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016301:Alveolar Bone Loss / Q000145:classification; D002118:Calcium / Q000737:chemistry*; D002130:Calcium Phosphates / Q000737:chemistry; D020099:Coated Materials, Biocompatible / Q000737:chemistry*; D045662:Dental Etching / Q000379:methods; D015921:Dental Implants; D003764:Dental Materials / Q000737:chemistry*; D019094:Dental Prosthesis, Implant-Supported; D019232:Dental Restoration Failure; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D057893:Immediate Dental Implant Loading / Q000379:methods*; D008297:Male; D008875:Middle Aged; D049329:Nanostructures / Q000737:chemistry; D010865:Pilot Projects; D011183:Postoperative Complications; D012449:Safety; D016037:Single-Blind Method; D013499:Surface Properties; D014025:Titanium / Q000737:chemistry*; D016896:Treatment Outcome
D002130:Calcium Phosphates; D020099:Coated Materials, Biocompatible; D015921:Dental Implants; D003764:Dental Materials; D014025:Titanium; D002118:Calcium