Norton Michael R
Int J Oral Maxillofac Implants. 2019 January/February;34(1):215–222. doi: 10.11607/jomi.6964. Epub 2018 Oct 3.
Purpose: The purpose of this study was to analyze the implant stability quotient (ISQ) values recorded by three commercially available resonance frequency analysis (RFA) instruments from a large cohort of implants in order to determine their accuracy and agreement with one another both for static measurements of ISQ at a given time and for change in ISQ over time.
Materials and Methods: A cohort of n = 210 implants had their primary stability, secondary stability, or both evaluated in both the mesiodistal (MD) and buccolingual (BL) directions by means of ISQ using three different RFA instruments: Osstell ISQ (O), Osstell IDx (O), and the Penguin (PG). ISQ values were recorded both at the time of implant placement and at 3 months postinsertion prior to definitive restoration. All values were tabulated for a blinded statistical analysis using Bland-Altman plots to determine if the outcome values were in agreement both for primary and secondary stability. In addition, a subgroup was evaluated to determine if change in ISQ was also in agreement. An intraclass correlation (ICC) was used to measure the reliability of the measurements for each instrument.
Results: Bland-Altman plots confirmed that there was a high agreement for MD values between O and O, with 72.7% of readings being within one ISQ unit and 94.7% within four units. Comparing PG to OISQ, the respective values at one and four units were 15.3% and 82.3%, and comparing PG to O, the respective values were 16.3% and 85.2%. In general, there was a greater uncertainty in the BL values having wider variability and demonstrating less agreement between instruments, with the percentage of readings falling within four units reducing to 85.9% (O vs O), 72.3% (PG vs O), and 74.3% (PG vs O). For change in ISQ over time, 92.3% of values were in agreement to within four units between instruments O and O in the MD direction and 73% in the BL direction. The respective percentage changes of values in agreement within four units for PG vs O were 76.9% and 60.3% and for PG vs O were 80% and 53.8%. The paired t test from mixed effects revealed that there was a significant difference for mean MD values between PG vs O; P = .015 with a mean 0.823 units higher was recorded for PG. Similarly for PG vs O, P = .008 with a mean 0.871 units higher was recorded for PG. For mean BL values between PG vs O, P = .000 with a mean 1.161 units higher was recorded for PG, and finally, for O vs O, P = .005 with a mean 0.597 units higher was recorded for O. However, the maximum upper and lower bound estimated bias between any two instruments was only 1.86 units and 0.46 units both for PG vs O in the BL direction, and it is doubtful that this is of clinical relevance even if statistically significant. ICC revealed that for static MD measurements, there was an 85% reliability between all three instruments (range: 79% to 97%). For BL measurements, the reliability value was 66% (range: 69% to 71%). When considering ICC for changes in ISQ values over time in the MD direction, there was a 70% reliability between all three instruments (range: 58% to 94%). For BL measurements, the reliability value was 58% (range: 46% to 91%).
Conclusion: Differences exist between instruments to some extent, most notably between the Penguin and the two instruments from Osstell, which showed good agreement to each other. While differences in evaluating ISQ with the PG were statistically significant, they were less than 1.86 units at the upper bound limit, and it is doubtful that this is of clinical relevance. Increased variability and reduced reliability for BL values render these less clinically sound when trying to assess primary stability.
本研究旨在分析三种市售共振频率分析(RFA)仪器记录的种植体稳定性商数(ISQ)值,该分析来自大量种植体队列,以确定它们在给定时间对ISQ静态测量的准确性和相互间的一致性,以及ISQ随时间的变化情况。
一组n = 210颗种植体,使用三种不同的RFA仪器:Osstell ISQ(O)、Osstell IDx(O)和Penguin(PG),通过ISQ在近远中(MD)和颊舌(BL)方向评估其初期稳定性、二期稳定性或两者。在种植体植入时以及最终修复前植入后3个月记录ISQ值。所有值进行列表,使用Bland-Altman图进行盲法统计分析,以确定初期和二期稳定性的结果值是否一致。此外,评估一个亚组以确定ISQ的变化是否也一致。使用组内相关系数(ICC)测量每种仪器测量的可靠性。
Bland-Altman图证实,O和O之间MD值有高度一致性,72.7%的读数在一个ISQ单位内,94.7%在四个单位内。将PG与OISQ比较,一个单位和四个单位时的相应值分别为15.3%和82.3%,将PG与O比较,相应值分别为16.3%和85.2%。总体而言,BL值的不确定性更大,变异性更大,仪器间一致性更低,四个单位内读数的百分比降至85.9%(O与O)、72.3%(PG与O)和74.3%(PG与O)。对于ISQ随时间的变化,在MD方向上仪器O和O之间92.3%的值在四个单位内一致,在BL方向上为73%。PG与O在四个单位内一致的值的相应百分比变化分别为76.9%和60.3%,PG与O分别为80%和53.8%。混合效应的配对t检验显示,PG与O之间MD值的平均值存在显著差异;P = 0.015,PG记录的平均值高0.823个单位。同样,对于PG与O,P = 0.008,PG记录的平均值高0.871个单位。对于PG与O之间BL值的平均值,P = 0.000,PG记录的平均值高1.161个单位,最后,对于O与O,P = 0.005,O记录的平均值高0.597个单位。然而,在BL方向上,任何两种仪器之间估计的最大上下界偏差仅为1.86个单位和0.46个单位,即使具有统计学意义,这是否具有临床相关性也值得怀疑。ICC显示,对于静态MD测量,所有三种仪器之间的可靠性为85%(范围:79%至97%)。对于BL测量,可靠性值为66%(范围:69%至71%)。当考虑MD方向上ISQ值随时间变化的ICC时,所有三种仪器之间的可靠性为70%(范围:58%至94%)。对于BL测量,可靠性值为58%(范围:46%至91%)。
仪器之间在一定程度上存在差异,最明显的是Penguin与Osstell的两种仪器之间,后者相互间显示出良好的一致性。虽然使用PG评估ISQ的差异具有统计学意义,但在上界极限时小于1.86个单位,则这是否具有临床相关性值得怀疑。BL值变异性增加和可靠性降低使得在评估初期稳定性时临床意义较小。