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

Neus Carrió; Basel El Garawani; Ayman Alahmad; Fares Atari; Eduard Ferrés-Amat; Joseph Bassil; Islam A Amer; Mai Badrah; Alshaimaa A Shabaan; Islam Kassem

doi:10.1186/s12903-026-09296-1

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

BMC Oral Health. 2026 Jul 20;26(1):1314. doi: 10.1186/s12903-026-09296-1.

Authors

Affiliations

¹ Periodontology Department, Universitat Internacional de Catalunya (UIC), C/Josep Trueta s/n, Barcelona, 08195, Spain.
² Maxillofacial Surgery Department, Alexandria University Hospital, Alexandria University, Alexandria, Egypt.
³ King Hussein Medical Center, Amman, Jordan.
⁴ Al-Balqa' Applied University, Al Salt, Jordan.
⁵ Oral Surgery Department, Universidad Católoca San Antonio Murcia, Murcia, Spain.
⁶ Faculty of Dental Medicine, Saint Joseph University of Beirut, Beirut, Lebanon.
⁷ General Surgery Department, Faculty of Medicine, Sohag University, Sohag, Egypt.
⁸ Internal Medicine Diabetes and Metabolism Department, Alexandria University, Alexandria, Egypt.
⁹ Oral & Maxillofacial Surgery Department, Fayoum University, Fayoum, Egypt.
¹⁰ Maxillofacial Surgery Department, Alexandria University Hospital, Alexandria University, Alexandria, Egypt. ikassem@dr.com.

Abstract

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.

Keywords: Burning mouth syndrome; Calcium chloride; Magnesium chloride; Neuropathic pain; Oral rinse; Randomized trial; Theravex Technology, THERAVEX® Total Oral Care Plus.

Publication types

Randomized Controlled Trial

MeSH terms

Aged
Burning Mouth Syndrome* / drug therapy
Calcium* / administration & dosage
Calcium* / therapeutic use
Double-Blind Method
Female
Humans
Magnesium* / administration & dosage
Magnesium* / therapeutic use
Male
Middle Aged
Mouthwashes* / therapeutic use
Pain Measurement
Treatment Outcome

Substances

Mouthwashes
Magnesium
Calcium

Associated data

ClinicalTrials.gov/NCT07564843