目的:设计生物活性表面以增加表面与细胞之间的相互作用。这可以加速生物稳定性和装载方案。
方法:纳入36例D3-D4骨密度患者,分为两组。放置30个生物活性物质(测试组)和30个传统(对照组)表面植入物。插入扭矩值(Ncm),插入扭矩曲线积分(累积扭矩,Ncm),扭矩密度(Ncm/sec),在三个时间点测量的植入物稳定性商(ISQ)(基线(T0),手术后30(T30)和45(T45)天),评估负荷6个月时的边缘骨丢失(MBL)。
结果:试验组T0、T30、T45的ISQ平均值和标准差分别为74.57±7.85、74.78±7.31、74.97±6.34,对照组为77.12±5.83、73.33±6.13、73.44±7.89,分别。数据分析显示,在T0-T30(p=0.005)和T30-T45(p=0.012)的ΔISQ之间存在显着差异。与基线相比,对照组在T30(p=0.01)和T45(p=0.03)时ISQ显着降低,试验组无明显变化。由于ISQ值≥70的稳定性,在45天后对26个测试组和23个对照组的植入物进行了功能性加载。相反,由于在T45时的ISQ<70,在90天后加载了四个测试组植入物和一个对照组植入物,180天后加载6个对照组植入物。基线时的插入扭矩和ISQ均与骨密度(以Hounsfield为单位)无关。基线时累积扭矩和ISQ之间没有显著相关性。基线时扭矩密度和ISQ之间的相关性存在显著的正斜率,D3比D4更突出。在第30天和第45天,D3骨中的测试组的这种相关性仍然显着(在两个时间范围内,p<0.01)。但不是在D4骨,在CG中并不显著。
结论:在骨愈合的早期阶段,生物活性表面在D3-D4骨质量的植入物稳定性方面表现出更好的行为。临床相关性这项研究表明,使用生物活性表面改善了从初级到次级稳定性的转变,特别是在骨骼环境较差的情况下(D3/D4骨骼)。
OBJECTIVE: Bioactive surfaces were designed to increase the interaction between the surface and the cells. This may speed up the biological stability and loading protocols.
METHODS: 36 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.
RESULTS: The 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 < 70 at T45, four test group implants and one control group implant were loaded after 90 days, and 6 control group implants were loaded after 180 days. Neither insertion torque nor ISQ at baseline were correlated with bone density (in Hounsfield units). There was no significant correlation between cumulative torque and ISQ at baseline. There was a significant positive slope in the correlation between torque density and ISQ at baseline, more accentuated in D3 than D4. This correlation remained significant for the test group in D3 bone at day 30 and 45 (p < 0.01 in both time frames), but not in D4 bone, and it was not significant in CG.
CONCLUSIONS: The bioactive surface showed better behavior in terms of implant stability in D3-D4 bone quality in the early stages of bone healing. Clinical relevance This study demonstrated that the transition from primary to secondary stability is improved using bioactive surface, especially in cases of poor bone environment (D3/D4 bone).