Nano-superhydrophilic and bioactive surface in poor bone environment. Part 1: transition from primary to secondary stability. A controlled clinical trial

ObjectivesBioactive surfaces were designed to increase the interaction between the surface and the cells. This may speed up the biological stability and loading protocols.Materials and methods36 patients with D3-D4 bone density were recruited and allocated into two groups. 30 bioactive (test group) and 30 traditional (control group) surfaced implants were placed. Insertion torque value (Ncm), insertion torque curve integral (cumulative torque, Ncm), torque density (Ncm/sec), implant stability quotient (ISQ) measured at three timepoints (baseline (T0), 30 (T30) and 45 (T45) days after surgery), and marginal bone loss (MBL) at 6 months of loading were assessed.ResultsThe mean ISQ and standard deviation at T0, T30, T45 were respectively 74.57 ± 7.85, 74.78 ± 7.31, 74.97 ± 6.34 in test group, and 77.12 ± 5.83, 73.33 ± 6.13, 73.44 ± 7.89 in control group, respectively. Data analysis showed significant differences between groups in ΔISQ at T0-T30 (p = 0.005) and T30-T45 (p = 0.012). Control group showed a significant decrease in ISQ at T30 (p = 0.01) and T45 (p = 0.03) compared to baseline, while no significant change was observed in test group. Due to the stability of the ISQ value ≥ 70, 26 test group and 23 control group implants were functionally loaded after 45 days. Conversely, due to the ISQ