A randomized, multicenter, double-blinded parallel study to evaluate the safety and performance of zoledronate-coated versus uncoated dental implants in partially edentulous patients

Abstract

Objective: To evaluate patient safety, implants survival and implant stability of the bisphosphonate (zoledronate) as a coating on dental implants in patients requiring oral rehabilitation in the posterior maxilla.

Materials and methods: In this multicenter, double-blind, randomized controlled study, 62 patients were randomized to receive either zoledronate-coated or uncoated control implants in the premolar or molar area of the maxilla, using a one stage-protocol. Due to dropouts and exclusion 49 patients completed the study. The implants were examined by resonance frequency analysis (RFA) using an implant stability quotient (ISQ) scale at the time of insertion, and at 8 weeks, and after 12 weeks prior to prosthetic restoration. Radiographs were taken prior to surgery, directly after insertion, and during the follow-up at 12 weeks, 6 months, and 1 year to analyze changes in marginal bone levels (MBL). Finally, all complications and adverse effects (AE) were observed and recorded.

Results: Out of 62 included patients, 49 patients completed the study. No AE were reported by patients receiving zoledronate-coated implants. There was no statistically significant difference between the zoledronate-coated or uncoated implant groups when comparing ISQ levels at insertion and after 12 weeks of healing, the mean of the ISQ values demonstrated a change of 4.64 (95% confidence interval: 15.46; 5.79, p = 0.43) between the two groups. At 8- and 12-weeks, ISQ values remained stable (range 62-70). Radiographic analysis showed no statistically significant difference in MBL between the two implant groups after 1 year of loading neither at the mesial side (p = 0.99) or the distal side (p = 0.97). MBL for coated implants were 0.57 mm at the mesial side and 0.46 mm at the distal side. For the uncoated implants, MBL was 0.48 mm at the mesial side and 0.47 mm at the distal side.

Conclusion: The zoledronate-coated dental implants are safe to use in a one-stage surgery protocol in patients requiring oral rehabilitation in the posterior maxilla, after 1 year of loading. There were no statically significant changes in implant stability and marginal bone levels measured by intraoral radiographs in comparison to uncoated control implants.

Keywords: bisphosphonates; bone healing; dental implant; marginal bone loss; radiographic evaluation; zoledronate; zoledronic acid.