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

Summary

In a double-blind RCT (n=116), an 8-week magnesium–calcium ionic oral rinse significantly reduced burning pain versus placebo (mean difference −1.7 NRS; 95% CI −2.5 to −0.9) and improved OHIP-14 and xerostomia scores, with mild, comparable adverse events. Findings support a mineral-ionic topical approach for primary BMS.

Key Findings

• Pain reduction vs placebo at 8 weeks: mean difference −1.7 NRS (95% CI −2.5 to −0.9; P<0.001).
• Responder rate (≥2-point NRS reduction): 62% active vs 32% placebo (P=0.001).
• Significant improvements in OHIP-14 and xerostomia scores; adverse events were mild and similar between groups.

Clinical Implications

Offers a non-systemic, well-tolerated option that can be integrated into BMS management, potentially reducing reliance on systemic agents with adverse effects.

Limitations

• Retrospective trial registration may introduce reporting bias concerns.
• Short 8-week duration without long-term durability or relapse assessment; single product and regimen.

Future Directions

Conduct multicenter, longer-term RCTs; compare against standard systemic therapies; elucidate mechanisms of ionic microenvironment modulation; explore dosing and combination strategies.