Department of Periodontology and Implant Dentistry, New York University, New York, USA.
Vilnius Research Group, Vilnius, Lithuania.
Clin Oral Investig. 2021 Nov;25(11):6127-6137. doi: 10.1007/s00784-021-03912-w. Epub 2021 Apr 16.
To assess the osseointegration and crestal bone level maintenance of a novel fully tapered self-cutting tissue-level implant for immediate placement (test) compared to a clinically established tissue-level implant (control) in moderate bone quality.
Test and control implants were compared in 3 groups, i.e., small-, medium-, and large-diameter implants in an edentulous mandibular minipig model with moderate bone quality after 12 weeks of healing. Histometrically derived bone-to-implant contact (BIC) and first bone-to-implant contact (fBIC) were subjected to statistical non-inferiority testing. Maximum insertion torque values in artificial bone were assessed for comparison.
BIC values for the tests and control implants for all 3 diameters were comparable and non-inferior: small diameter (61.30 ± 10.63% vs. 54.46 ± 18.31%) (p=0.99), medium diameter (60.91 ± 14.42 vs. 54.68 ± 9.16) (p=0.55), and large diameter (45.60 ± 14.67 vs. 52.52 ± 14.76) (p=0.31). fBIC values for test implants were higher and non-inferior compared to control implants in all three groups. Test implants further showed distinctly higher maximum insertion torque values compared to control implants.
The investigated novel tissue-level implant is able to achieve high levels of primary and secondary implant stability under simultaneous preservation of crestal bone levels. This qualifies the studied implant as an attractive candidate for immediate placement in bone of limited quality.
This pilot pre-clinical study investigated a novel tissue-level implant for immediate placement. With the aim of translating the studied prototype into clinical application pre-clinical models, procedures and controls have been chosen with the aim of reflecting its future clinical indication and use.
评估一种新型全锥形自切割组织水平种植体即刻植入（试验）与临床已建立的组织水平种植体（对照）在中骨量条件下的骨整合和颊侧骨水平维持情况。
在中骨量的无牙下颌 mini 猪模型中，将试验和对照种植体分别在小、中、大直径三组中进行比较，每组各植入 12 周。通过组织学测量获得的骨-种植体接触（BIC）和首次骨-种植体接触（fBIC）进行非劣效性检验。评估人工骨中的最大植入扭矩值进行比较。
所有三种直径的试验和对照种植体的 BIC 值相似且具有非劣效性：小直径（61.30±10.63%比 54.46±18.31%）（p=0.99），中直径（60.91±14.42 比 54.68±9.16）（p=0.55）和大直径（45.60±14.67 比 52.52±14.76）（p=0.31）。试验组的 fBIC 值在所有三组中均高于对照种植体，且具有非劣效性。试验组进一步显示出明显高于对照种植体的最大植入扭矩值。
所研究的新型组织水平种植体在同时保持颊侧骨水平的情况下，能够达到高水平的初级和次级种植体稳定性。这使研究种植体成为在质量有限的骨中即刻植入的有吸引力的候选者。
本研究为一项新型组织水平即刻种植体的初步临床前研究。为了将研究原型转化为临床应用，本研究选择了临床前模型、程序和对照，旨在反映其未来的临床适应证和用途。
