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Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome
Sponsor: Federal University of Minas Gerais
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2023-11-01
Completion Date
2026-07-10
Last Updated
2026-06-29
Healthy Volunteers
No
Conditions
Interventions
topical placebo rinse
Participants rinsed with a placebo solution (0.1% saccharin, 0.05% flavoring, 1% paraben solution, propylene glycol q.s. 20 mL; no active ingredient) compounded by Manipulatta Pharmacy (Belo Horizonte, MG) to be organoleptically identical to clonazepam (Rivotril®) in color, flavor, and odor. Ten drops were diluted in 10 mL of water and swished near the painful sites for 3 minutes without swallowing, then expectorated. The protocol was repeated three times daily for 21 days. Solution was provided in two 20 mL amber vials.
topical clonazepam rinse
Participants rinsed with a clonazepam solution (Rivotril® 2.5 mg/mL; 10 drops = 1 mg) diluted in 10 mL of water, holding the liquid near the painful sites for 3 minutes without swallowing, then expectorating. The protocol was repeated three times daily for 21 days. Each participant received two 20 mL amber vials of the clonazepam 2.5 mg/mL solution.
oral alpha-lipoic acid capsule
Participants in this group will be instructed to take oral capsules containing alpha-lipoic acid.
topical phytotherapic capsaicin gel
Participants in this group will to apply the gel containing tocapsaicin on painful oral sites.
local photobiomodulation
Photobiomodulation will be applied during 10 seconds per point at 56 points (three on the vestibular mucosa of the 4 quadrants, four on each labial mucosa, six on each of the two buccal mucosae, six on the hard palate, four on each lateral edge of the tongue, six on the dorsum of the tongue, and four sublingual points) with an intermediate distance of 2 mm. A dose of 12 J/cm² per session will be applied in continuous mode for 10 sessions. The 10 sessions will be applied twice a week for 5 consecutive weeks. The LASER will be applied perpendicularly in contact with the mucosa. All patients and the clinician will wear protective glasses.
Locations (1)
Federal university of minas gerais
Belo Horizonte, Minas Gerais, Brazil