Clinical Trial

Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome

Active, Not Recruiting Phase 4
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Record status
This record was last updated June 29, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
Burning Mouth Syndrome (BMS) is characterized by a burning sensation on the tongue or other areas of the mouth, often bilateral but occasionally unilateral. It is more prevalent in postmenopausal women. No specific ethnic or socioeconomic predisposition has been identified. The etiology and pathophysiology of BMS remain unknown. Various treatment approaches have been proposed, yielding conflicting outcomes and underscoring the need for further investigation. Patients with BMS appear to respond well to long-term therapy involving systemic antidepressants and anxiolytics. The most promising therapeutic effects have been observed with clonazepam, which leads to a significant reduction in pain when applied topically or systemically. Capsaicin, an herbal remedy, also presents as an alternative treatment option, showing positive results in alleviating BMS symptoms when compared to a placebo. Photobiomodulation represents another non-pharmacological treatment possibility. It's analgesic action is possibly attributed to the inhibition of pain mediators. Alpha-lipoic acid (ALA) is dietary supplement employed in BMS treatment. It serves as a potent antioxidant naturally produced within the body, contributing to the mitigation of skin aging and reinforcing the effects of other biological antioxidants. Based on these findings, attempts have been made to demonstrate ALA's effectiveness in BMS management, concluding that ALA may offer benefits in this context. Therefore, the objective of this study is to investigate, in adults with BMS, the impact of different therapeutic approaches on frequency, intensity, and location of pain, as well as on on quality of life.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-09-10; most recent amendment 2026-06-25.
Status change: Recruiting → Active, Not Recruiting 2026-06-25
Status change: Not Yet Recruiting → Recruiting 2024-02-21
Trial Details
NCT Number NCT06040190
Lead Sponsor Federal University of Minas Gerais
Conditions Burning Mouth Syndrome
Enrollment 150 participants
Start Date 2023-11-01
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-07-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-29