drugset / Trial / NCT06040190

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

NCT06040190

Phase 4 Active not recruiting 150 enrolled Federal University of Minas Gerais
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2023-11-01
Primary completion
2026-07-01
Completion
2026-07-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Capsaicin Small molecule 0.025 mg Topical
Subject Clonazepam Small molecule 1 mg Topical
Subject alpha-lipoic acid Small molecule 300 mg Oral