Borie Manon, Lecloux Geoffrey, Bosshardt Dieter, Barrantes Alejandro, Haugen Håvard Jostein, Lambert France, Bacevic Miljana
Department of Periodontology and Oral Surgery, University Hospital of Liège, Belgium.
Robert K. Schenk Laboratory of Oral Histology, School of Dental Medicine, University of Bern, Switzerland.
Contemp Clin Trials Commun. 2020 Aug 15;19:100643. doi: 10.1016/j.conctc.2020.100643. eCollection 2020 Sep.
Recently, there has been a growing interest in mucointegration as the formation of an early and long-standing soft tissue barrier seems essential for both the initial healing and long-term implant survival.
To develop an experimental method to characterize the mucointegration of different transgingival materials (titanium (Ti), polyetheretherketone (PEEK), polymethylmethacrylate (PMMA), zirconia (Zi), polymer infiltrated ceramic network (PICN), cobalt-chrome (Co-Cr), and lithium disilicate (LD)) in a human model.
The study is designed as a multi-part randomized controlled clinical trial. Ninety bone level Straumann implants will randomly receive an experimental, custom-made abutment to allow for the removal of the abutment together with the surrounding soft tissues using a punch biopsy device at 8 weeks of healing (10 per material). The specimens will be further processed for non-decalcified histology, followed by histomorphometric analysis. The same protocol will be used for additional 90 implants-abutments, but during harvesting, soft tissues will be separated from the abutment and processed for immunohistochemistry in order to study tissue inflammation and vascularization, while the abutments will undergo SEM analysis. Additionally, analyses, including SEM and profilometry, will be performed in order to characterize surface topography of all experimental materials.
The limited number of pilot samples presented herein indicate that the use of custom-made abutments in humans is a reproducible method to study peri-implant soft tissue integration. This further intensifies the rationale to compare different abutment materials, used as transgingival components in daily practice, under the same conditions.
近来，人们对微整合的兴趣日益浓厚，因为早期和长期存在的软组织屏障的形成似乎对初期愈合和种植体的长期存活都至关重要。
开发一种实验方法，以在人体模型中表征不同龈上材料（钛（Ti）、聚醚醚酮（PEEK）、聚甲基丙烯酸甲酯（PMMA）、氧化锆（Zi）、聚合物渗透陶瓷网络（PICN）、钴铬（Co-Cr）和二硅酸锂（LD））的微整合情况。
本研究设计为多部分随机对照临床试验。90颗骨水平的士卓曼种植体将随机接受一个实验性的定制基台，以便在愈合8周时使用打孔活检装置移除基台及其周围的软组织（每种材料10个）。标本将进一步进行非脱钙组织学处理，随后进行组织形态计量分析。另外90个种植体 - 基台将采用相同方案，但在取材时，软组织将与基台分离并进行免疫组织化学处理以研究组织炎症和血管化，而基台将进行扫描电子显微镜分析。此外，将进行包括扫描电子显微镜和轮廓测定法在内的分析，以表征所有实验材料的表面形貌。
本文展示的有限数量的试点样本表明，在人体中使用定制基台是研究种植体周围软组织整合的一种可重复方法。这进一步强化了在相同条件下比较日常实践中用作龈上部件的不同基台材料的理论依据。
