Document Type : Original Article
Authors
1
Membership of Dental Material Research Center, School of Dentistry, Islamic Azad University, Tehran Medical Branch, Tehran, Iran.
2
Dept. Oral Medicine, Membership of Dental Material Research Center, School of Dentistry, Islamic Azad University, Tehran Medical Branch, Tehran, Iran. Student of Medical Education, School of Medical Education and Learning Technologies, Shahid Beheshti University of Medical sciences, Tehran, Iran.
3
Dept. Oral Medicine, School of Dentistry, Islamic Azad University, Tehran Medical Branch, Tehran, Iran.
4
Dept. of Traditional Pharmacy, Faculty of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran.
5
Dental Student, Membership of Dental Material Research Center, School of Dentistry, Islamic Azad University, Tehran Medical Branch, Tehran, Iran.
10.30476/dentjods.2026.111315.3029
Abstract
Background: Burning mouth syndrome (BMS) is a chronic oral pain disorder characterized by a persistent burning sensation in clinically normal oral mucosa. Its complex and unclear etiology has limited effective treatment options. Capsaicin has been proposed as a potential therapy; however, evidence regarding capsaicin oral solutions remains limited.
Purpose: To evaluate the effect of a novel capsaicin oral solution on burning mouth symptoms, salivary flow, xerostomia, and oral health-related quality of life in patients with BMS.
Materials and Method: This double-blind, parallel randomized controlled trial included 22 eligible female patients with BMS who were randomly assigned to capsaicin (n= 11) or placebo (n= 11). Both groups received vitamin B complex and zinc supplementation during the 30-day intervention. Participants in the capsaicin group used 10 drops of capsaicin oral solution diluted in one tablespoon of water as a mouth rinse twice daily for 1 minute, while the placebo group followed the same protocol using an identical placebo solution. Burning severity (visual analog scale), non-stimulated salivary flow (modified Schirmer’s test), xerostomia symptoms, and oral health-related quality of life were assessed at baseline and day 30.
Results: Baseline demographic and clinical characteristics were comparable between groups (p Value > 0.05). At day 30, no statistically significant between-group differences were observed for burning severity, non-stimulated salivary flow, xerostomia symptoms, or oral health-related quality of life (all p> 0.05). Within-group analyses demonstrated significant improvements in burning severity, salivary flow, and selected xerostomia and quality-of-life measures in the capsaicin group (all p< 0.05); these findings were considered secondary and exploratory.
Conclusion: Capsaicin oral solution did not demonstrate statistically significant superiority over placebo in improving BMS-related outcomes. Larger multicenter randomized controlled trials with longer treatment duration and follow-up are warranted to clarify the potential role of capsaicin as an adjunctive therapy for BMS.
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