Scholarlink

Introduction <p>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.</p> <p>This study aimed to evaluate the efficacy and safety of magnesium-calcium oral rinse(test oral rinse)in patients with primary BMS.</p> Materials and Methods <p>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.</p> <p>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.</p> Results <p>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&lt;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.</p> Conclusion <p>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.</p> Trial Registration <p>ClinicalTrials.gov NCT07564843, registered on 27 Abril 2026. Retrospectively registered.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年7月20日

查看全文
  • Neus Carrió,
  • Basel El Garawani,
  • Ayman Alahmad,
  • Fares Atari,
  • Eduard Ferrés-Amat,
  • Joseph Bassil,
  • Islam A. Amer,
  • Mai Badrah,
  • Alshaimaa A. Shabaan,
  • Islam kassem

摘要

Introduction

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.

Materials and Methods

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.

Results

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.

Conclusion

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.

Trial Registration

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