Silk‐fibroin chitosan film for palatal wounds: Material development, in vitro study, and pilot clinical trial

This study aimed to evaluate a novel silk fibroin and chitosan film for treating palatal mucosa wounds. The films were sterilized, tested for physical properties, such as thickness, tensile strength, elongation, water vapor permeability, and swelling, and subjected to scanning electron microscopy. In vitro tests using human oral and skin cells assessed the film's toxicity. Ten patients undergoing graft-harvesting procedures received the film, and their healing was monitored clinically, immunologically, and histologically. The film demonstrated appropriate physical properties, and laboratory results indicated high cell viability and low toxicity. Clinically, the wounds demonstrated considerable closure by Day 7 and almost full closure by Day 14. Immunological assessments indicated elevation in some healing markers, and histology revealed no residual biomaterial at 12 months post treatment. Complete epithelialization occurred by Day 21, with no tissue thickness loss at 90 days, and patients reported low discomfort and minimal analgesic use. These findings suggest that the silk-fibroin/chitosan film may be beneficial for oral wound healing, warranting further clinical studies to confirm its efficacy.