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

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.

Conditions

• Burning Mouth Syndrome

Interventions

DRUG

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.

DRUG

topical clonazepam rinse

Participants were instructed to rinse with a solution containing 10 drops of clonazepam (Rivotril®️) at 2.5 mg/mL (0.1 mg/drop, according to the manufacturer's specifications), diluted in 10 mL of water, keeping the solution in the oral cavity, close to the painful sites, for 3 minutes without swallowing, followed by expectoration. This protocol was repeated three times daily for 21 days. Each participant received two 20-mL amber bottles of clonazepam solution at 2.5 mg/mL.

DIETARY_SUPPLEMENT

oral alpha-lipoic acid capsule

Participants in this group will be instructed to take oral capsules containing alpha-lipoic acid.

OTHER

topical phytotherapic capsaicin gel

Participants in this group will to apply the gel containing tocapsaicin on painful oral sites.

RADIATION

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.

Sponsors & Collaborators

• Federal University of Minas Gerais

  lead OTHER

Principal Investigators

• Fernando O Costa, PhD · Federal University of Minas Gerais

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-01

Primary Completion

2026-07-01

Completion

2026-07-01

Countries

• Brazil

Study Locations