10 February 2022

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Comparison between single early-loaded implants with sandblasted acid-etched (SA) surface versus SA surface modified with pH buffering agent (SOI): four-month data from a split-mouth, multicentre randomized controlled trial

Authors: L. Zadrożny, E. Xhanari, M. Gheorghita, A. De Waal, N. Widmer, L. Muzzi, E. Deliverska, F. Gatti, M. Czajkowska, J. Buti, A. Alushi, M. Tallarico

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PURPOSE. To compare implant survival and success rates and implant stability quotient (ISQ) values of early-loaded single implants with sandblasted acid-etched (SA, control group) surface versus implants with SA surface modified with pH buffering agent (SOI, test group).

MATERIALS AND METHODS. This study was designed as multicentre, split-mouth, randomized controlled trial to evaluate implant and prosthesis survival rates, complications, and implant stability quotient (ISQ) in any partially edentulous subject requiring at least two single implant-supported crowns. A one-stage implant placement procedure was used, and implants were randomized after implant site preparation. ISQ values were evaluated for each implant, at baseline and then every week up to 8 weeks after surgery, and finally at definitive crown delivery (12 weeks after implant placement).

RESULTS. Overall, 62 patients from 9 centres were enrolled in this study. One patient dropped out from the study at 8 weeks. In the first 12 weeks of observation, 2 implants failed, both in the SA group, the difference not being statistically significant (P = 0.5). No prosthesis failure occurred up to 4 months after fitting. Five complications were experienced, 3 in the SA group and 2 in the SOI group. The difference between groups was not statistically significant (OR = 0.66, 95% CI: 0.11 to 4.07; P = 0.650). Of these complications, loss of stability without rotation was observed in 2 implants from the SOI group and 2 implants from the SA group, all in the third and fourth weeks of measurements. All the implants were submerged and successfully osseointegrated at the twelfth week. The last complication was an SA implant screw loosening, which was resolved chair-side. The baseline mean ISQ values were 76.57 ± 7.54 (95% CI 74.69 to 78.44) in the SA group and 75.92 ± 7.69 (95% CI 73.89 to 77.73) in the SOI group. The mean ISQ values at 12 weeks were 79.17 ± 7.83 (95% CI 77.03 to 81.29) and 78.82 ± 8.80 (95% CI 76.42 to 81.21) in the SA and SOI groups, respectively. Mixed-effects modelling revealed a statistically significant difference between groups over time, with slightly lower ISQ values for the SOI group (-0.65; 95% CI -1.14 to -0.15). Statistically significant differences were also estimated among centres (P <0.001).

CONCLUSIONS. Within the limitations of the present preliminary report, it is possible to conclude that both implants can be successfully loaded early.