Actively Recruiting

Phase 4
Age: 18Years - 70Years
All Genders
NCT06040190

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Federal university of minas gerais

Belo Horizonte, Minas Gerais, Brazil

Actively Recruiting

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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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