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种植体的骨整合比较——临床前体内研究


目的以组织计量方式比较新型锥形自切割组织水平测试种植体与标准组织水平对照种植体在浸没愈合方案中的骨整合和牙槽嵴骨愈合情况。材料和方法在下颌小型猪模型中插入种植体并进行组织计量评估经过 3、6 和 12 周的愈合期后。主要结果是骨与种植体接触 (BIC) 的评估，次要结果是根据插入扭矩和第一 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对测试种植体和对照种植体的结果进行比较。结果与对照种植体 (35.2 ± 19.7 Ncm， p =.0071）。在研究期间，测试种植体的 BIC 值并不劣于对照种植体。 12周后，测得的相应值为81.62±11.12%和90.41±4.81%（ p = .1763) 分别用于测试和对照植入物。同样，fBIC 值也没有发现统计学差异，但 12 周结果显示，与对照种植体 (-182.75 ± 197.40 μm) 相比，测试值 (-675.58 ± 590.88 μm) 在统计上较低。 p = .0068).结论新型自切割组织级种植体表现出与组织级种植体相比不较差的骨整合和牙槽嵴骨高度维持能力。两种种植体之间的组织测量结果表明，尽管骨接合机制存在显着差异，并导致插入扭矩和定性骨愈合模式存在差异，但测试种植体在统计上并不劣于对照种植体。