Department of Periodontology, School of Dental Medicine, University of Bern, Bern, Switzerland.
Department of Preclinical Research, Institut Straumann AG, Basel, Switzerland.
Clin Oral Implants Res. 2024 Oct;35(10):1299-1309. doi: 10.1111/clr.14318. Epub 2024 Jul 20.
To 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.
In 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.
Insertion 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).
Novel 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.
通过对比新型锥形自切式软组织水平种植体与标准软组织水平对照种植体在淹没愈合方案中的骨整合和边缘骨愈合情况，进行组织学测量。
在一个下颌骨小型猪模型中，在愈合期 3、6 和 12 周后，通过组织学测量评估种植体。主要结果是评估骨-种植体接触（BIC），次要结果是根据初始插入扭矩和首次 BIC（fBIC）评估初始稳定性。使用 Wilcoxon 符号秩检验和混合线性回归模型比较试验和对照种植体的结果。
试验组（50.0±26.4 Ncm）的插入扭矩值明显高于对照组（35.2±19.7 Ncm，p=0.0071）。在整个研究期间，试验组的 BIC 值与对照组相比无差异。在 12 周后，测量的相应值分别为 81.62±11.12%和 90.41±4.81%（p=0.1763）。同样，fBIC 值也没有发现统计学差异，除了 12 周的结果显示试验组的 fBIC 值明显低于对照组（-675.58±590.88μm），差异具有统计学意义（p=0.0068）。
新型自切式软组织水平种植体具有与软组织水平种植体相当的骨整合和边缘骨高度维持能力。尽管在骨结合机制和由此导致的插入扭矩和定性骨愈合模式方面存在显著差异，但两种种植体的组织学结果表明，试验组在统计学上与对照组相当。
