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.

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

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinsk bioteknologi -- Biomaterialvetenskap (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Medical Biotechnology -- Biomaterials Science (hsv//eng)

Nyckelord

Adult

Aged

Aged

80 and over

Alveolar Bone Loss

classification

Calcium

chemistry

Calcium Phosphates

chemistry

Coated Materials

Biocompatible

chemistry

Dental Etching

methods

Dental Implants

Dental Materials

chemistry

Dental Prosthesis

Implant-Supported

Dental Restoration Failure

Female

Follow-Up Studies

Humans

Immediate Dental Implant Loading

methods

Male

Middle Aged

Nanostructures

chemistry

Pilot Projects

Postoperative Complications

Safety

Single-Blind Method

Surface Properties

Titanium

chemistry

Treatment Outcome

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