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

Federal University of Minas Gerais

Status and phase: Enrolling; Phase 4

Conditions: Burning Mouth Syndrome

Treatments: Drug: topical clonazepam tablet; Other: topical phytotherapic capsaicin gel; Drug: topical placebo tablet; Radiation: local photobiomodulation; Dietary Supplement: oral alpha-lipoic acid capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06040190

6.161.933

Details and patient eligibility

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 6 patient groups, including a placebo group

topical placebo tablet

Placebo Comparator group

Description:

magnesium silicate placebo tablet three times a day for 21 days

Treatment:

Drug: topical placebo tablet

control

No Intervention group

Description:

artificial saliva

topical clonazepam tablet

Experimental group

Description:

2.0 mg Clonazepam tablet three times a day for 21 days

Treatment:

Drug: topical clonazepam tablet

oral alpha-lipoic acid capsule

Experimental group

Description:

300 mg alpha-lipoic acid capsule twice a day for 60 days

Treatment:

Dietary Supplement: oral alpha-lipoic acid capsule

topical phytotherapic capsaicin gel

Experimental group

Description:

0.025 mg capsaicin gel 4 times a day for 14 days

Treatment:

Other: topical phytotherapic capsaicin gel

local photobiomodulation

Experimental group

Description:

Photobiomodulation with wavelength of 810 nm, power of 0.6 W, power density of 1.2 W/cm², beam area of 0.5 cm², and energy of 6 J.

Treatment:

Radiation: local photobiomodulation