Abstract
BACKGROUND: Oral submucous fibrosis (OSF) is a chronic, progressive, and irreversible fibrotic disorder of the oral mucosa that is strongly associated with areca nut consumption. It is classified as an oral potentially malignant disorder (OPMD) with one of the highest malignant transformation rates (4%-7%). Despite extensive research across Asia and globally, significant heterogeneity persists in diagnostic criteria, grading systems, and management strategies. This hinders effective clinical practice, surveillance, and public health policymaking. By integrating translational evidence on areca nut-associated fibrosis, oral potentially malignant disorders, and oral cancer into a consensus-driven framework, this manuscript advances biologically informed, equitable, and collaborative strategies for oral cancer prevention and early risk reclassification in resource-limited settings. METHODS: This guideline was developed through a structured consensus process modelled on the ACCORD reporting framework for consensus-based biomedical research. A multi-institutional steering committee was convened, and included senior oral pathologists and clinicians: Vinay Hazarey (VH), WM Tilakaratne (WMT), Kannan Ranganathan (KR), Raghu Radhakrishnan (RR), Jayanta Chattopadhyay (JC), Punnya V Angadi (PA), Karishma Desai (KD), and Pratibha Ramani (PR) (as a moderator from Saveetha Dental College, Chennai). The panel head was Dinesh Daftary (DD). Evidence was synthesised from peer-reviewed publications indexed in PubMed, Scopus, and Web of Science. Consensus was defined as ≥80% agreement following structured rounds of discussion. The recommendations were graded as Strong or Conditional according to the quality of evidence, feasibility, and global applicability. RESULTS: The panel achieved a consensus on key areas: (1) OSMF is caused primarily by areca nut, a Group I carcinogen with no safe level of use; (2) clinical diagnosis should combine functional limitations with mucosal changes, supported by histopathology that incorporates fibrosis severity and epithelial dysplasia; (3) management should prioritize habit cessation, supplemented by pharmacological and surgical interventions as appropriate; (4) malignant transformation warrants long-term surveillance and potential revision of staging for OSMF-related oral cancer; and (5) strong public health measures are urgently needed, including regulation of areca nut sales and the establishment of centres of Excellence for OPMDs. CONCLUSIONS: These WHO-style guidelines provide an evidence-based, globally relevant framework for the diagnosis, management, and prevention of OSMF. The emphasis should be on early detection, habit cessation, translational research, and policy reforms. The adoption of these recommendations will strengthen clinical practice and reduce the burden of OSMF, and associated oral cancer worldwide.