Theravex® for Burning Mouth Syndrome

Inclusion Criteria: Adults aged ≥18 years. Diagnosis of primary Burning Mouth Syndrome (BMS) according to International Classification of Orofacial Pain (ICOP) and ICHD-3 criteria. Daily intraoral burning or dysaesthetic sensation persisting for ≥3 months and occurring ≥2 hours per day. Clinically normal oral mucosa without visible lesions. Absence of identifiable local or systemic causes of oral burning following standard diagnostic workup. Ability and willingness to comply with study procedures and provide written informed consent. Exclusion Criteria: Presence of secondary causes of oral burning (e.g., oral candidiasis, nutritional deficiencies, uncontrolled diabetes mellitus, thyroid disorders). Autoimmune diseases affecting the oral cavity (e.g., Sjögren syndrome). Active oral mucosal pathology or lesions. Pregnancy or breastfeeding. Known hypersensitivity to any component of the study product. Use of topical clonazepam, capsaicin, systemic neuromodulators, or other treatments for BMS within 14 days prior to enrollment. Severe psychiatric disorders or conditions that could interfere with study participation or outcome assessment.