Key Takeaways & Executive Findings
- •• The polylactic acid/collagen bilayer membrane fabricated by electrospinning exhibits a dense layer with smaller fiber diameter and pore size, and a loose layer with larger fiber diameter and pore size, providing a suitable structure for guided tissue regeneration. • Glutaraldehyde vapor cross-linking was selected as the optimal method, yielding a cross-linking degree of 17.42% and improved mechanical properties. • The membrane shows asymmetric wettability: the loose layer is hydrophilic while the dense layer is hydrophobic, which may facilitate cell attachment and barrier function. • Comprehensive biocompatibility tests confirmed that the membrane is non-cytotoxic, non-hemolytic, non-pyrogenic, non-toxic, non-irritating, and non-sensitizing, indicating excellent biocompatibility for clinical application.
Abstract
BACKGROUND: Marine collagen can promote the proliferation and differentiation of periodontal ligament fibroblasts and the proliferation of vascular endothelial cells. However, simple collagen membranes have low mechanical strength and rapid degradation, necessitating composite materials. Polylactic acid, a biodegradable medical material approved by the US Food and Drug Administration for implantation, can be composited with collagen to improve the mechanical strength of simple collagen. OBJECTIVE: To prepare a polylactic acid/collagen electrospinning bilayer guided tissue regeneration membrane and investigate its biocompatibility. METHODS: A 7% polylactic acid solution was used as the spinning dope for the dense layer and a 14% polylactic acid-collagen solution was used as the spinning dope for the loose layer. The polylactic acid/collagen double-layer guided tissue regeneration membrane was prepared by electrospinning technology. The membranes were characterized for micromorphology, pore size, and porosity. The membranes were cross-linked using three methods: glutaraldehyde vapor, glutaraldehyde solution, and carbodiimide/hydroxysuccinimide. Tensile tests were performed to identify the membranes with the best mechanical properties for subsequent experiments. The hydrophilic and hydrophobic properties of the membrane were evaluated by water contact angle measurements. The biocompatibility of the membrane was evaluated by cytotoxicity test, pyrogen test, hemolysis test, acute systemic toxicity test, subchronic systemic toxicity test, sensitization test, and intradermal irritation test. RESULTS AND CONCLUSION: The dense layer of the polylactic acid/collagen electrospinning bilayer guided tissue regeneration membrane had a fiber diameter of (0.45±0.11) μm, pore size of (2.43±1.31) μm, and porosity of (29.86±2.89)%. The loose layer had a fiber diameter of (0.85±0.19) μm, pore size of (11.71±4.41) μm, and porosity of (48.54±1.33)%. Based on the tensile strength, elastic modulus, and elongation at break, glutaraldehyde vapor cross-linking was selected, with a cross-linking degree of (17.42±1.67)%. The loose layer exhibited hydrophilicity, while the dense layer exhibited hydrophobicity. The polylactic acid/collagen electrospinning bilayer guided tissue regeneration membrane showed no cytotoxicity, no hemolysis, no pyrogenicity, no potential toxicity, no irritation, and no sensitization, indicating good biocompatibility.
1. Introduction
Alveolar surgery, dental implantation, maxillofacial trauma fractures, tumors, and certain congenital diseases often lead to bone tissue damage. The regeneration and repair of guided bone defects is a key focus in the fields of biomaterials and tissue engineering [1]. With the development of related research, introducing biomaterials to assist bone regeneration and repair has become a more efficient method, known as guided tissue regeneration membrane technique [2], and the materials used are called guided tissue regeneration membranes.
After bone defect formation, surrounding fibrous tissue occupies the space for bone regeneration, leading to suboptimal bone regeneration outcomes. Therefore, some scholars proposed using a biological membrane to isolate periodontal tissue from alveolar bone, preventing soft tissue ingrowth into the alveolar bone defect, thereby achieving alveolar bone defect repair [3]. This is the earliest hypothesis of guided tissue regeneration. The ideal characteristics of guided tissue regeneration membranes include: certain mechanical properties and strength to maintain structural integrity in the complex in vivo environment, preventing membrane rupture and collapse; barrier function to isolate fibrous tissue from growing into the bone defect during bone repair; appropriate degradation performance that matches the timing of bone regeneration and tissue repair; and good biocompatibility, requiring no adverse reactions when implanted in the body. Increasing evidence shows that guided tissue regeneration membranes play a crucial role in bone regeneration [4-7], thus membranes with good biocompatibility have attracted much attention.
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SONG Muze, LIU Chuyi, TANG Qingjuan, DAI Yuankun, SONG Wenshan, LI Bafang, WANG Yuanyuan (2026). Biocompatibility evaluation of polylactic acid/collagen electrospinning bilayer guided tissue regeneration membrane. Chinese Journal of Tissue Engineering Research. https://doi.org/10.12307/2026.21464
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Frequently Asked Questions
What is the purpose of the polylactic acid/collagen bilayer membrane?
The membrane is designed for guided tissue regeneration, particularly for oral bone defect repair. It combines the biocompatibility of collagen with the mechanical strength of polylactic acid to provide a barrier that prevents soft tissue ingrowth while supporting bone regeneration.
How was the membrane fabricated?
The membrane was fabricated using electrospinning technology. A 7% polylactic acid solution was used for the dense layer, and a 14% polylactic acid-collagen solution was used for the loose layer, resulting in a bilayer structure.
What cross-linking method was selected and why?
Glutaraldehyde vapor cross-linking was selected because it provided the best mechanical properties (tensile strength, elastic modulus, and elongation at break) among the three methods tested, with a cross-linking degree of 17.42%.
What are the key biocompatibility results?
The membrane showed no cytotoxicity, no hemolysis, no pyrogenicity, no potential toxicity, no irritation, and no sensitization, indicating excellent biocompatibility for clinical use.
What are the advantages of using marine collagen?
Marine collagen avoids the risk of zoonotic diseases and religious restrictions associated with mammalian collagen. It also promotes the proliferation and differentiation of periodontal ligament fibroblasts and vascular endothelial cells, which are beneficial for tissue regeneration.
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