Effect of a bioactive rapidly resorbing silica containing calcium alkaliphosphate bone grafting material on osteo-, angiogenesis and micromechanic bone properties in biopsies 6 months after sinus floor augmentation as compared to tricalcium phosphate and

与磷酸三钙和磷酸三钙相比，含有生物活性快速吸收二氧化硅的碱式磷酸钙骨移植材料对窦底增强后 6 个月活检中的骨、血管生成和微机械骨特性的影响

• 批准号: 529650786
• 负责人: Professorin Dr. Christine Knabe-Ducheyne
• 金额: --
• 依托单位: Abteilung für Orofaziale Prothetik und Funktionslehre
• 依托单位国家: 德国
• 项目类别: Research Grants
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/529650786?language=en
• 关键词: Effect; bioactive; rapidly; resorbing; silica

Over the last few decades there has been an ever increasing search for adequate bone grafting materials in implant dentistry for use for sinus floor augmentation (SFA) and alveolar ridge augmentation. For most clinically available bone grafting materials, however, data which would provide a detailed characterization of the cell and tissue responses to these materials including data derived from clinically representative large animal models and clinical studies are extremely scarce. An ideal bone grafting material should be highly bioactive and stimulate osteogenesis, while resorbing rapidly at the same time, thereby facilitating copious and expeditious bone formation and bone regeneration with fully functional bone, which then in its turn facilitates earlier implant placement and shorter treatment durations. As a result, a former DFG funded project succeeded in developing a highly bioactive silica containing calcium alkali orthophosphate (Si-CAOP) bone grafting material and in demonstrating greater bone formation and biodegradability as well as a greater stimulatory effect on osteogenesis, when compared to tricalcium phosphate (TCP), in the context of a clinically representative large animal model and in vitro. When using TCP for SFA, high clinical success rates were achieved. TCP, however, resorbs within 1-2 years in humans. Since Si-CAOP was cleared by the FDA and received the CE mark on the basis of the data generated in the previously funded DFG projects, the proposed project aims at confirming the excellent osteogenic properties of Si-CAOP and greater stimulatory effect on bone formation when compared to TCP, which were demonstrated in the context of these previous projects, in human tissue, so as to obtain successful translation into the clinical arena. To this end, the correlation between the signal transduction data as well as the data generated in the context of the large animal sheep study and data obtained by analyzing patient biopsies and radiological data will be established in order to facilitate the evidence-based use of Si-CAOP in patients (on the basis of robust comprehensive data sets). As a result, the effect of Si-CAOP on osteogenesis and angiogenesis will be characterized in biopsies obtained from 30 patients 6 months after SFA at implant placement, and compared to that of TCP, utilizing comprehensive, cutting-edge hard tissue histologic, immunohistochemical and synchrotronmicrotomographic and micromechanic analyses. This is in addition to evaluating the volume stability of the grafted region on the basis of cone beam CT data. Hence, the proposed project aims at testing the hypothesis that the superior osteogenic properties, which were previously demonstrated in vitro and in vivo, will also result in markedly enhanced bone formation in patient tissue when using Si-CAOP for SFA as compared to TCP. If this hypothesis will be confirmed, earlier implant placement after 4 instead of 6 months after SFA can be justified ethically.

在过去的几十年里，在种植牙科学中越来越多地寻找用于窦底提升（SFA）和牙槽嵴提升的适当骨移植材料。然而，对于大多数临床可用的骨移植材料，能够提供细胞和组织对这些材料反应的详细表征的数据（包括来自临床代表性大型动物模型和临床研究的数据）极其缺乏。理想的骨移植材料应具有高生物活性并刺激骨生成，同时快速吸收，从而促进大量和快速的骨形成和具有完全功能的骨的骨再生，这反过来又有助于更早的植入物放置和更短的治疗时间。因此，一个前DFG资助的项目成功地开发了一种高生物活性的含硅碱性正磷酸钙（Si-CAOP）骨移植材料，并在临床代表性大型动物模型和体外试验中，与磷酸三钙（TCP）相比，证明了更大的骨形成和生物降解性以及对骨生成的更大刺激作用。当使用TCP治疗SFA时，临床成功率很高。然而，TCP在人体中在1-2年内被再吸收。由于Si-CAOP已获得FDA批准，并根据先前资助的DFG项目中生成的数据获得CE标志，因此拟定项目旨在证实Si-CAOP在人体组织中具有优异的成骨特性，并且与TCP相比对骨形成具有更大的刺激作用，这些特性在先前项目的背景下得到了证实，以便成功转化为临床竞技场。为此，将建立信号转导数据以及在大型动物绵羊研究背景下生成的数据与通过分析患者活检和放射学数据获得的数据之间的相关性，以促进Si-CAOP在患者中的循证使用（基于稳健的综合数据集）。因此，Si-CAOP对骨生成和血管生成的影响将在种植体放置时SFA后6个月从30名患者获得的活检中进行表征，并与TCP进行比较，利用全面的尖端硬组织组织组织学，免疫组织化学和同步辐射显微断层扫描和显微力学分析。这是在锥形束CT数据的基础上评价移植区域体积稳定性的补充。因此，拟定项目旨在检验以下假设：与TCP相比，当将Si-CAOP用于SFA时，先前在体外和体内证明的上级成骨特性也将导致患者组织中骨形成的显著增强。如果这一假设将得到证实，那么在SFA术后4个月而不是6个月后早期植入种植体在伦理上是合理的。