Abstract
The present in vivo study analyses both the inflammatory tissue reactions and the bone healing capacity of a newly developed bone substitute material (BSM) based on xenogeneic bone substitute granules combined with hyaluronate (HY) as a water-binding molecule. The results of the hyaluronate containing bone substitute material (BSM) were compared to a control xenogeneic BSM of the same chemical composition and a sham operation group up to 16 weeks post implantationem. A major focus of the study was to analyze the residual hyaluronate and its effects on the material-dependent healing behavior and the inflammatory tissue responses. The study included 63 male Wistar rats using the calvaria implantation model for 2, 8, and 16 weeks post implantationem. Established and Good Laboratory Practice (GLP)-conforming histological, histopathological, and histomorphometrical analysis methods were conducted. The results showed that the new hyaluronate containing BSM was gradually integrated within newly formed bone up to the end of the study that ended in a condition of complete bone defect healing. Thereby, no differences to the healing capacity of the control BSM were found. However, the bone formation in both groups was continuously significantly higher compared to the sham operation group. Additionally, no differences in the (inflammatory) tissue response that was analyzed via qualitative and (semi-) quantitative methods were found. Interestingly, no differences were found between the numbers of pro- and anti-inflammatory macrophages between the three study groups over the entire course of the study. No signs of the HY as a water-binding part of the BSM were histologically detectable at any of the study time points, altogether the results of the present study show that HY allows for an optimal material-associated bone tissue healing comparable to the control xenogeneic BSM. The added HY seems to be degraded within a very short time period of less than 2 weeks so that the remaining BSM granules allow for a gradual osteoconductive bone regeneration. Additionally, no differences between the inflammatory tissue reactions in both material groups and the sham operation group were found. Thus, the new hyaluronate containing xenogeneic BSM and also the control BSM have been shown to be fully biocompatible without any differences regarding bone regeneration.
Highlights
The clinical application of bone substitute materials (BSM) has become an integral part of daily routine in various parts of medicine and dentistry
Bone graft pastes based on calcium phosphate (CaP) granules combined with water-binding molecules such as collagen, cellulose, or hyaluronate (HY) are used in dentistry [39]
In the case of synthetic BSM, it has been shown that they undergo degradation via (a) dissolution to calcium and phosphate ions in the organism and (b) cellular degradation or phagocytosis mediated by macrophages and multinucleated giant cells (MNGCs) [41]
Summary
The clinical application of bone substitute materials (BSM) has become an integral part of daily routine in various parts of medicine and dentistry. It has been revealed that BSM perform to autologous bone transplants, superseding their application in many indications [6,7,8]. A variety of preclinical and clinical studies have already shown that the application of xenogeneic BSMs lead to predictable bone formation due to their excellent osteoconductive properties [11,12,13]. In this context, it has been revealed that xenogeneic BSMs are beneficial for oral and maxillofacial surgery in indications such as sinus augmentation procedures, providing a long-term scaffold for successful subsequent insertion of dental implants [14,15]
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