A comparison of two dental implant systems in partially edentulous patients: 1-year post-loading results from a pragmatic multicentre randomised controlled trial.

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Abstract

PURPOSE: To compare the clinical effectiveness of two implant systems: Way Milano and Kentron (Geass, Pozzuolo del Friuli, UD, Italy). MATERIALS AND METHODS: A total of 64 patients requiring at least two single crowns or partial fixed dental prostheses supported by a maximum of three implants had their sites randomised according to a split-mouth design to receive both implant systems at six centres. Patients were followed up for 1 year after initial loading. Outcome measures were: prosthesis/implant failures; any complication; peri-implant marginal bone level changes; and clinician preference. RESULTS: In total 71 Way Milano and 73 Kentron implants were placed. Six patients dropped-out before the 1-year follow-up, but all remaining patients were followed up to 1 year post-loading. No Way Milano implant failed, whereas three Kentron implants failed before loading. Two complications were reported, one for each implant type. There were no statistically significant differences for prosthesis/implant failures (difference in proportions = 0.05, P = 0.25; 95% CI -0.02 to 0.13) and complications (difference in proportions = 0, P = 1.0, 95% CI -0.07 to 0.07) between the implant systems. Three operators preferred Way Milano implants whereas the other three had no preference. At implant placement (baseline) bone levels were higher for Way Milano implants (0.27 mm) than for Kentron implants (0.41 mm). Both groups gradually lost statistically significant amounts of periimplant marginal bone at 4 months after loading and at 1 year after loading. One year after loading, Way Milano implants lost an average of 0.73 mm peri-implant bone compared with 0.84 mm of Kentron implants. Marginal bone level changes were not statistically significant different for Way Milano compared to Kentron implants at 4 months (-0.16 mm, 95% CI -0.30, 0.01; P = 0.0606) and 1 year (-0.09 mm, 95% CI -0.26, 0.09; P = 0.3407) after loading. CONCLUSIONS: No statistically significant differences were observed between the two implant types, although three Kentron implants failed versus none of the Way Milano type. Longer follow-up of wider patient populations are needed to better understand whether there is an effective advantage with one of the two implant designs. Conflict of interest statement: This trial was partially funded by Geass (Pozzuolo del Friuli, UD, Italy), the manufacturer of the implants evaluated in this investigation. However, the data belonged to the authors and by no means did the manufacturer interfere with the conduct of the trial or the publication of the results.

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