Development of Hydrophilic Electrospun (Es) PLA/Bioceramic Guided Tissue/Bone Regeneration (GT/GBR) Membranes

The guided tissue/bone regeneration (GTR/GBR) membranes are frequently applied in oral surgery for periodontal disease and alveolar bone regeneration. However, clinical usages of GTR/GBR membranes need to rely on imported products, since there is no domestic manufacturer for this product in Taiwan. Our team has successfully developed a novel poly(lactic acid) (PLA)/biocerimic GTR/GBR membrane via electrospinning (ES) technique in previous project. This established proprietary technology for producing the GTR/GBR membranes with superior physical-chemical property than that of commercial products. Therefore, the aims of this project are to commercialize this novel hydrophilic electrospun PLA/bioceramic GTR/GBR membrane with conducting biocmopatitlity, animal tests and clinical trial. A two-year project is proposed. In the first year, the membranes will be prepared in clean room (class 10,000) with the scale of 400 pieces/batch (1.5 × 2.0 mm2). PLA/bioceramic membranes will be assayed under the biocompatibility guidelines of ISO-10993. The animal study of 21 Lanyu pigs with periodontal defect model will be carried on to evaluate the cementum height change and new bone gain for prototype PLA and PLA/bioceramic memnranes and commercial product, Epiguide®. In the second year, the pilot production of GTR/GBR membranes will be used for clinical trial to confirm the efficacy for periodontal treatment and alveolar bone regeneration, respectively. It will shed some light on the factors that influence the success of GTR barriers and the future research directions.