Trial reportBMC oral health2026
Efficacy of magnesium-calcium ionic oral rinse for primary burning mouth syndrome: a randomized, double-blind, placebo-controlled trial.
Trial report in BMC oral health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07564843 (Mineral-ionic Magnesium/Calcium Oral Rinse), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Mineral-ionic Magnesium/Calcium Oral Rinse (THERAVEX® Total Oral Care Plus) in Primary Burning Mouth Syndrome: a Double-blind Randomized Placebo-controlled Trial
Who cites it
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Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPrimary 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
methodsIn 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.
resultsAt 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.
conclusionMagnesium-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 registrationClinicalTrials.gov NCT07564843, registered on 27 Abril 2026. Retrospectively registered.
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