Neodent, Curitiba, Brazil.
Biomedical Center, Faculty of Medicine, Lund University, Lund, Sweden.
Clin Oral Investig. 2021 Feb;25(2):603-615. doi: 10.1007/s00784-020-03513-z. Epub 2020 Sep 10.
This study compared the osseointegrative potential of a novel injection molded zirconia dental implant (Neodent Zi ceramic implant, test) and a commercially available titanium implant (Neodent Alvim implant, control) in terms of histomorphometrically derived bone-to-implant contact (BIC), first bone-to-implant contact (fBIC), and the ratio of bone area to total area (BATA) around the implant.
A total of 36 implants, 18 per individual test device, were implanted in a split-mouth arrangement in either side of the edentulous and fully healed mandible of 6 minipigs. Histomorphometric analysis of BIC, fBIC, and BATA were performed 8 weeks post implantation and subjected to statistical non-inferiority testing. Surface characteristics of both implant types were compared in terms of contact angle, surface topography, and elemental composition.
BIC, fBIC, and coronal BATA values of test and control implants were statistically comparable and non-inferior. BIC values of 77.8 ± 6.9% vs. 80.7 ± 6.9% (p = 0.095) were measured for the test and control groups. fBIC lingual values were - 238 ± 328 μm compared with - 414 ± 511 μm (p = 0.121) while buccal values were - 429 ± 648 μm and - 588 ± 550 μm (p = 0.230) for the test and control devices, respectively. BATA in the apical segment was significantly higher in the test group compared with the control group (67.2 ± 11.8% vs. 59.1 ± 11.4%) (p = 0.0103). Surface topographies of both implant types were comparable. Surface chemical analysis indicated the presence of carbonaceous adsorbates which correlated with a comparable and predominantly hydrophobic character of the implants.
The results demonstrate that the investigated zirconia implants, when compared with a commercially available titanium implant, show equivalent and non-inferior bone integration, bone formation, and alveolar bone level maintenance. This qualifies the investigated zirconia implant as a potential candidate for clinical development.
This study investigated the osseointegration of a novel zirconia 2-piece dental implant prototype intended for clinical development. With the aim of translating this prototype into clinical development preclinical models, procedures and materials within this study have been selected as close to clinical practice and human physiological conditions as possible.
本研究比较了一种新型注塑氧化锆牙科种植体（Neodent Zi 陶瓷种植体，试验）和一种市售钛种植体（Neodent Alvim 种植体，对照）的骨整合潜力，方法是通过组织形态计量学获得种植体周围的骨-种植体接触（BIC）、首次骨-种植体接触（fBIC）和骨面积与总面积比（BATA）。
将 36 个种植体（每个个体试验装置 18 个）以双侧分牙的方式植入 6 只小型猪无牙和完全愈合的下颌骨中。种植后 8 周进行 BIC、fBIC 和 BATA 的组织形态计量学分析，并进行非劣效性统计检验。比较两种种植体的表面特性，包括接触角、表面形貌和元素组成。
试验组和对照组的 BIC、fBIC 和冠部 BATA 值在统计学上无差异且具有非劣效性。试验组和对照组的 BIC 值分别为 77.8±6.9%和 80.7±6.9%（p=0.095）。试验组和对照组的 fBIC 舌侧值分别为-238±328μm和-414±511μm（p=0.121），颊侧值分别为-429±648μm和-588±550μm（p=0.230）。试验组根尖段的 BATA 值明显高于对照组（67.2±11.8% vs. 59.1±11.4%）（p=0.0103）。两种种植体的表面形貌相当。表面化学分析表明存在碳质吸附物，这与种植体具有相似的、主要是疏水性的特性相关。
研究结果表明，与市售钛种植体相比，所研究的氧化锆种植体具有相同的、非劣效的骨整合、骨形成和牙槽骨水平维持能力。这使所研究的氧化锆种植体有资格成为临床开发的候选者。
本研究调查了一种新型氧化锆 2 段式牙种植体原型的骨整合情况，该种植体旨在进行临床开发。为了将该原型转化为临床开发，本研究选择了尽可能接近临床实践和人体生理条件的预处理模型、程序和材料。
