Characterization of electrospun acid polylactic-co-glycolic (PLGA) and PLGA/Gelatin membranes, for use in Guided Bone Regeneration (GBR): ANVISA registration purposes

• Grant number: 23/16911-4
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: October 01, 2024
• End date: June 30, 2025
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Gabriela Gomes Cardoso Gastaldi
• Grantee: Gabriela Gomes Cardoso Gastaldi
• Company: Soluções em Biotecnologia 3D - Engenharia Tecidual Ltda
• CNAE: Pesquisa e desenvolvimento experimental em ciências sociais e humanas ; Reparação e manutenção de equipamentos eletroeletrônicos de uso pessoal e doméstico
• City: Campinas
• Pesquisadores principais: Ana Luíza Garcia Millás Massaguer
• Associated researchers: André Antonio Pelegrine ; Elizabeth Ferreira Martinez

Abstract

Bone defect regeneration remains a challenge in Periodontology and Implantology. The invasion of epithelial and connective tissues into the defect can hinder bone neoformation and cause unsatisfactory defect regeneration, potentially compromising predictability and the aesthetic and functional prognosis in oral rehabilitation. Guided Bone Regeneration (GBR) is a surgical technique that utilizes membranes, which can be associated with bone substitutes for volume maintenance and optimization of bone defect regeneration. The objective of this project is the physical-chemical and biological in vitro characterization of two bilayer membranes developed for GBR application. The membranes made from electrospinning technology consist of poly-lactic-co-glycolic acid (PLGA), a synthetic polymer, and gelatin, a collagen-derived protein, imparting hydrophilicity to the material. The two membranes, 1) PLGA and 2) PLGA/Gelatin electrospun, will be manufactured as described in the patent (BR 10 2022 025750 7 A2). The membranes will be characterized to quantify and qualify their properties for Guided Bone Regeneration (GBR) according to ISO 10993-1:2013: "Biological evaluation of medical devices" and ISO 10993-18: "Chemical characterization of materials." Comparative in vitro and in vivo biological analyses of PLGA and PLGA/Gelatin membranes from 3DBS will also be performed with a synthetic and a biological commercial membrane, according to ISO 10993-5 (2009), which deals with cell line interactions: L929 (C3H Mouse/An Adipose Tissue) and osteoblastic cells SAOS-2 (HTB-85TM) targeted for GBR. The project is supported by São Leopoldo Mandic School of Medicine and Dentistry with the participation of professors Dr. Elizabeth Ferreira Martinez and Dr. André Antonio Pelegrine. (AU)