Clinical Evaluation of an Electrospun Chitosan/Polyvinyl Alcohol Nanofibrous Membrane Used as an Open-Healing Barrier for Ridge Preservation After Mandibular Premolar Extraction: A Randomized Split-Mouth Clinical Trial Protocol

Abstract Background Alveolar ridge resorption following tooth extraction may compromise subsequent restorative procedures. Electrospun chitosan/polyvinyl alcohol (CS/PVA) nanofibrous membranes exhibit favorable biological and mechanical properties; however, high-quality clinical evidence supporting their use as standalone barriers under open-healing conditions is limited. Objectives This protocol describes a randomized split-mouth clinical trial designed to evaluate the effectiveness of CS/PVA nanofibrous membrane for ridge preservation following mandibular premolar extraction. Methods Eligible participants requiring bilateral mandibular premolar extraction will be enrolled. Test sites will receive CS/PVA membrane, while control sites will heal naturally. Primary outcomes include horizontal and vertical ridge dimensional changes, keratinized tissue width, and histomorphometric parameters. Secondary outcomes include soft tissue healing, soft tissue thickness gain, and adverse events. Outcomes will be assessed over a 4-month healing period using blinded evaluation and paired statistical analysis. Discussion This trial is designed to address current evidence gaps by isolating the barrier effect of CS/PVA nanofibrous membranes in intact sockets under open-healing conditions. Trial Registration Thailand Clinical Trial Registry (TCTR). Registration number (ID: TCTR20251001001), Registered on 01/10/2025 (prospective registration). Trial Registration Prospective registration (TCTR20251001001).