Actively Recruiting
Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome
Led by Federal University of Minas Gerais · Updated on 2025-12-24
150
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of burning mouth syndrome
- Oral pain occurring daily for more than 2 hours per day for over 3 months
- Pain described as burning and felt superficially in the oral mucosa
- Normal appearance of the oral mucosa
- Normal oral clinical examination including sensory tests
You will not qualify if you...
- Pregnancy
- Presence of oral mucosal lesions
- Systemic diseases such as diabetes, anemia, or deficiencies in vitamins B1, B2, B6, B12, iron, zinc, or folic acid
- Gastroesophageal reflux
- Previous head and neck radiotherapy
- Sjogren's disease
- Allergies
- Candidiasis
- Unstimulated saliva flow less than 0.25 ml/min or stimulated saliva flow less than 1.0 ml/min
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Federal university of minas gerais
Belo Horizonte, Minas Gerais, Brazil
Actively Recruiting
Research Team
F
Fernando O Costa, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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