Efficacy of magnesium-calcium ionic oral rinse for primary burning mouth syndrome: a randomized, double-blind,...

Primary burning mouth syndrome (BMS) is a chronic idiopathic orofacial pain condition characterized by persistent intraoral burning sensation in the absence of clinically evident mucosal lesions. Its pathophysiology is considered multifactorial, with neuropathic mechanisms playing a central role. Current treatments are constrained by systemic adverse effects. Modulation of the oral mucosal ionic microenvironment has been proposed as a potential local therapeutic strategy. This study aimed to evaluate the efficacy and safety of magnesium-calcium oral rinse(test oral rinse)in patients with primary BMS.

In this randomized, double-blind, placebo-controlled trial, 116 adults with primary burning mouth syndrome (BMS) were assigned in a 1:1 ratio to receive magnesium-calcium oral rinse or placebo for 8 weeks. Participants rinsed 10 mL for 60 seconds three times daily. The primary outcome was change in burning pain intensity assessed using a Numeric Rating Scale (NRS). Secondary outcomes included the responder rate (≥2-point reduction in NRS), Oral Health Impact Profile-14 (OHIP-14), Xerostomia Inventory, Patient Global Impression of Change (PGIC), and safety assessments.

At week 8, the active group showed significantly greater reduction in pain compared with placebo (mean difference, -1.7; 95% CI, -2.5 to -0.9; P<0.001). Responder rates were 62% versus 32% (P=0.001). Significant improvements were also observed in OHIP-14 and xerostomia scores. Adverse events were mild and comparable between groups.

Magnesium-calcium oral rinse significantly reduced burning pain and improved oral health-related quality of life in patients with primary burning mouth syndrome, with a favorable safety profile. These findings support the potential role of mineral-ionic topical therapy in this condition.

ClinicalTrials.gov NCT07564843, registered on 27 Abril 2026. Retrospectively registered.