Bozkurt Ahmet, Apel Christian, Sellhaus Bernd, van Neerven Sabien, Wessing Bastian, Hilgers Ralf-Dieter, Pallua Norbert
Clin Oral Implants Res. 2014 Dec;25(12):1403-11. doi: 10.1111/clr.12284.
Collagen barrier membranes are used in guided bone regeneration/guided tissue regeneration because of their excellent bio- and cytocompatibility. However, they are considered to have limitations in clinical outcome because of rapid and unpredictable degradation profiles. The aim of this study was to investigate the degradation behavior of two porcine-based, non-cross-linked collagen membranes in vitro and in vivo.
Remaix™ (RX; Matricel GmbH, Herzogenrath, Germany) and Bio-Gide® (BG; Geistlich Pharma AG, Wolhusen, Switzerland) membranes were characterized by testing mechanical strength, denaturation temperature, enzymatic degradation and hydroxyproline content in vitro (n = 5 up to 16). Thereafter, both membranes were implanted subcutaneously in rats (n = 20) for up to 20 weeks to investigate tissue compatibility with respect to membrane thickness.
BG contained a significant higher hydroxyproline content compared with RX, but RX showed a higher stress at break (dry: 11.4 (SD 2.9) vs. 5.5 (SD 1.5) N/mm(2)), higher suture retention (wet: 5.6 (SD 1.3) vs. 2.7 (SD 0.7) N), increased denaturation temperature (55.1 (SD 1) vs. 49.4 (SD 0.6)°C) and an almost twofold reduction in degradation rate (15.6% (SEM 1.3)/h vs. 24.8% (SEM 2.9)/h) in vitro. In the rat model, both membranes showed excellent tissue compatibility without signs of inflammatory reactions. Shortly after implantation, RX and BG showed moderate infiltration of mononuclear cells that appeared not to be influenced by the surface texture of the membranes. In the histomorphometric analysis, both membranes showed significant different thickness over the 20 weeks period (P = 0.0002). Although the thickness remained almost stable during the first 9 weeks after implantation, after 20 weeks, the thickness of RX decreased only slightly, whereas BG showed a thickness loss of around 50% and stronger degradation than RX. Therefore, the higher stability of RX against biodegradation found in vitro was confirmed in the animal study.
This study shows differences in the biodegradation characteristics of two non-cross-linked collagen membranes in vitro and in vivo. Whether the higher stability of RX is of clinical relevance should be analyzed in future clinical investigations.
胶原屏障膜因其优异的生物相容性和细胞相容性而被用于引导骨再生/引导组织再生。然而，由于其快速且不可预测的降解特性，它们在临床效果方面被认为存在局限性。本研究的目的是在体外和体内研究两种猪源非交联胶原膜的降解行为。
通过测试体外的机械强度、变性温度、酶降解和羟脯氨酸含量对Remaix™（RX；德国黑措根拉特市Matricel GmbH公司）和Bio-Gide®（BG；瑞士沃尔胡森市盖斯特利制药股份公司）膜进行特性分析（n = 5至16）。此后，将两种膜皮下植入大鼠体内（n = 20）长达20周，以研究与膜厚度相关的组织相容性。
与RX相比，BG的羟脯氨酸含量显著更高，但RX的断裂应力更高（干燥状态：11.4（标准差2.9）对5.5（标准差1.5）N/mm²），缝线保留力更高（湿润状态：5.6（标准差1.3）对2.7（标准差0.7）N），变性温度更高（55.1（标准差1）对49.4（标准差0.6）°C），体外降解速率几乎降低了两倍（15.6%（标准误1.3）/小时对24.8%（标准误2.9）/小时）。在大鼠模型中，两种膜均显示出优异的组织相容性，无炎症反应迹象。植入后不久，RX和BG均显示出单核细胞的中度浸润，且似乎不受膜表面纹理的影响。在组织形态计量学分析中，两种膜在20周期间的厚度存在显著差异（P = 0.0002）。尽管植入后的前9周厚度几乎保持稳定，但20周后，RX的厚度仅略有下降，而BG的厚度损失约为50%，降解比RX更强。因此，在动物研究中证实了RX在体外对生物降解具有更高的稳定性。
本研究显示了两种非交联胶原膜在体外和体内生物降解特性的差异。RX更高的稳定性是否具有临床相关性应在未来的临床研究中进行分析。
