Dental implant treatment requires an available bone volume in the implantation site to ensure the implant’s mechanical stability. When the bone volume is insufficient, one must resort to surgical means such as guided bone regeneration (GBR). In GBR surgery, bone grafts and membranes are used. The objective of this work is to manufacture and characterize the in vitro and in vivo properties of resorbable collagen type I membranes (Green Membrane ® ) for GBR. Membrane surface morphology was characterized by SEM and roughness was measured using an interferometric noncontact 3D system. In vivo skin sensitization and toxicity tests have been performed on Wistar rats. Bone defects were prepared in 24 adult male rats, filled with biomaterials (Blue Bone ® and Bio Oss ® ) and covered with collagen membranes to maintain the mechanical stability of the site for bone regeneration. The incisions were closed with simple stitches; and 60 days after the surgery, the animals were euthanized. Results showed that the analyzed membrane was homogeneous, with collagen fiber webs and open pores. It had no sign of cytotoxicity and the cells at the insertion site showed no bone morphological changes. There was no tissue reaction and no statistical difference between Blue Bone ® and Bio Oss ® groups. The proposed membrane has no cytotoxicity and displays a biocompatibility profile that makes it suitable for GBR.

中文翻译：

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用于引导性骨再生应用的I型牛胶原蛋白膜的特性

牙科植入物治疗需要在植入部位有可用的骨量，以确保植入物的机械稳定性。当骨量不足时，必须采取外科手术手段，例如引导下的骨再生（GBR）。在GBR手术中，使用了骨移植物和膜。这项工作的目的是制造和表征用于GBR的可吸收I型胶原膜（Green Membrane®）的体外和体内特性。通过SEM表征膜表面形态，并使用干涉非接触式3D系统测量粗糙度。已在Wistar大鼠上进行了体内皮肤敏化和毒性测试。在24只成年雄性大鼠中准备了骨缺损，填充生物材料（Blue Bone®和Bio Oss®）并覆盖胶原蛋白膜，以保持骨骼再生部位的机械稳定性。切口用简单的针脚缝合；手术后60天，对动物实施安乐死。结果表明，所分析的膜是均匀的，具有胶原纤维网和开孔。它没有细胞毒性的迹象，并且插入部位的细胞没有显示出骨形态变化。Blue Bone®和Bio Oss®组之间没有组织反应，也没有统计学差异。提出的膜没有细胞毒性，并显示出生物相容性特征，使其适合GBR。结果表明，所分析的膜是均匀的，具有胶原纤维网和开孔。它没有细胞毒性的迹象，并且插入部位的细胞没有显示出骨形态变化。Blue Bone®和Bio Oss®组之间没有组织反应，也没有统计学差异。提出的膜没有细胞毒性，并显示出生物相容性特征，使其适合GBR。结果表明，所分析的膜是均匀的，具有胶原纤维网和开孔。它没有细胞毒性的迹象，并且插入部位的细胞没有显示出骨形态变化。Blue Bone®和Bio Oss®组之间没有组织反应，也没有统计学差异。提出的膜没有细胞毒性，并显示出生物相容性特征，使其适合GBR。