Treatments for Burning Mouth Syndrome and Their Effects on Pain and Quality of Life

Evaluation of the Effect of Different Treatments on Pain Scores and Self-reported Oral Health-related Quality of Life in Individuals With Burning Mouth Syndrome: a Randomized Controlled Clinical Trial

This study is testing different treatments for Burning Mouth Syndrome to see if they can help reduce pain and improve the quality of life for postmenopausal women dealing with this condition.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Federal University of Minas Gerais (Academic / other)
• Locations: 1 site (Belo Horizonte, Minas Gerais)
• Trial ID: NCT06040190 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of various treatments for Burning Mouth Syndrome (BMS), a condition characterized by a burning sensation in the mouth. Participants will receive different interventions, including topical clonazepam, oral alpha-lipoic acid, topical capsaicin gel, and local photobiomodulation, compared to a placebo. The study aims to evaluate the impact of these treatments on pain levels and overall quality of life for individuals suffering from BMS. The research is particularly focused on postmenopausal women, who are more commonly affected by this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with Burning Mouth Syndrome who experience daily oral pain for more than two hours over a three-month period.

Not a fit: Patients with systemic diseases, oral mucosal lesions, or those who are pregnant will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective treatment options for patients suffering from the debilitating symptoms of Burning Mouth Syndrome.

How similar studies have performed: Previous studies have shown promising results with similar treatment approaches for Burning Mouth Syndrome, particularly with clonazepam and capsaicin.

Eligibility criteria

Inclusion Criteria:

* burning mouth syndrome;
* oral pain that recurs daily for \> 2 hours per day for \> 3 months;
* pain with burning quality and felt superficially in the oral mucosa;
* oral mucosa appears normal
* oral clinical examination, including sensory tests, is normal;

Exclusion Criteria:

* pregnancy;
* oral mucosal lesions;
* systemic diseases such as diabetes, anemia, deficiency of vitamin B1, B2, B6, B12, Fe, Zinc, and folic acid;
* gastroesophageal reflux;
* previous head and neck radiotherapy;
* Sjogren's disease;
* allergies;
* candidiasis;
* unstimulated saliva flow \< 0.25 ml/min and stimulated flow \< 1.0 ml/min will be excluded;

Where this trial is running

Belo Horizonte, Minas Gerais

• Federal university of minas gerais — Belo Horizonte, Minas Gerais, Brazil (Recruiting)

Study contacts

• Principal investigator: Fernando O Costa, PhD — Federal University of Minas Gerais
• Study coordinator: Fernando O Costa, PhD

Conditions Burning Mouth Syndrome