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

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 | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol 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A Randomized Split-Mouth Clinical Trial Protocol Gamil Al-Madhagy, Khaldoun Darwich This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8929065/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version 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). Barrier membrane Guided bone regeneration Guided tissue regeneration Socket preservation Clinical trial protocol Chitosan Polyvinyl alcohol Nanofibers Full Text Additional Declarations No competing interests reported. Table 1 is available in the Supplementary Files section. Supplementary Files Table1.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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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.\u003c/p\u003e\u003cp\u003e\u003cb\u003eObjectives\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThis 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.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMethods\u003c/b\u003e\u003c/p\u003e \u003cp\u003eEligible 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.\u003c/p\u003e\u003cp\u003e\u003cb\u003eDiscussion\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThis 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.\u003c/p\u003e\u003cp\u003e\u003cb\u003eTrial Registration\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThailand Clinical Trial Registry (TCTR). 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