PurposeTo histometrically compare the osseointegration and crestal bone healing of a novel tapered, self‐cutting tissue‐level test implant with a standard tissue‐level control implant in a submerged healing regimen.Materials and MethodsIn a mandibular minipig model, implants were inserted and evaluated histometrically after a healing period of 3, 6, and 12 weeks. The primary outcome was the evaluation of bone‐to‐implant contact (BIC) and secondary outcomes were primary stability as per insertion torque and first BIC (fBIC). Outcomes for the test and control implants were compared using Wilcoxon signed‐rank tests and mixed linear regression models.ResultsInsertion torque values were significantly higher for the test (50.0 ± 26.4 Ncm) compared to the control implants (35.2 ± 19.7 Ncm, p = .0071). BIC values of test implants were non‐inferior to those of control implants over the investigated study period. After 12 weeks, the corresponding values measured were 81.62 ± 11.12% and 90.41 ± 4.81% (p = .1763) for test and control implants, respectively. Similarly, no statistical difference was found for fBIC values, except for the 12 weeks outcome that showed statistically lower values for the test (−675.58 ± 590.88 μm) compared to control implants (−182.75 ± 197.40 μm, p = .0068).ConclusionsNovel self‐cutting tissue‐level implants demonstrated noninferior osseointegration and crestal bone height maintenance to the tissue‐level implants. Histometric outcomes between both implants demonstrated test implants were statistically noninferior to control implants, despite substantial differences in the bone engagement mechanism and resulting differences in insertion torque and qualitative bone healing patterns.

中文翻译：

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疏水性组织水平锥形植入物的比较骨结合——一项临床前体内研究


目的在组织学上比较新型锥形、自切割组织水平测试植入物与浸没愈合方案中的标准组织水平对照植入物的骨整合和牙槽嵴愈合。材料和方法在下颌微型猪模型中，植入植入物并在 3 、 6 和 12 周的愈合期后进行组织测量评估。主要结果是骨与植入物接触 （BIC） 的评估，次要结果是根据插入扭矩和首次 BIC （fBIC） 的主要稳定性。使用 Wilcoxon 符号秩检验和混合线性回归模型比较测试植入物和对照植入物的结果。结果与对照植入物 （50.0 ± 26.4 Ncm，p = .0071） 相比，测试的插入扭矩值 （35.2 ± 19.7 Ncm） 显着更高。在调查的研究期间，测试植入物的 BIC 值不劣于对照植入物的 BIC 值。12 周后，测试±对照植入物的相应测量值分别为 81.62 ± 11.12% 和 90.41 4.81% （p = .1763）。同样，fBIC 值没有发现统计学差异，除了 12 周结果显示测试值 （-675.58 ± 590.88 μm） 与对照植入物 （-182.75 ± 197.40 μm，p = .0068） 相比，在统计学上较低。结论新型自切割组织水平植入物表现出非劣于组织水平植入物的骨整合和牙槽嵴骨高度维持。两种植入物之间的组织学结果表明，测试植入物在统计学上不劣于对照植入物，尽管骨接合机制存在很大差异，并且导致插入扭矩和定性骨愈合模式存在差异。