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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation, Dietary supplement, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
Brazil
Federal university of minas gerais
RECRUITING
Belo Horizonte
Contact Information
Primary
Fernando O Costa, PhD
focperio@uol.com.br
+55 31 9954-0657
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2025-10-01
Participants
Target number of participants: 150
Treatments
Placebo_comparator: topical placebo tablet
magnesium silicate placebo tablet three times a day for 21 days
No_intervention: control
artificial saliva
Experimental: topical clonazepam tablet
2.0 mg Clonazepam tablet three times a day for 21 days
Experimental: oral alpha-lipoic acid capsule
300 mg alpha-lipoic acid capsule twice a day for 60 days
Experimental: topical phytotherapic capsaicin gel
0.025 mg capsaicin gel 4 times a day for 14 days
Experimental: local photobiomodulation
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.
Related Therapeutic Areas
Sponsors
Leads: Federal University of Minas Gerais

This content was sourced from clinicaltrials.gov