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

NCT ID: NCT06040190

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-03-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

topical placebo tablet

magnesium silicate placebo tablet three times a day for 21 days

Group Type: PLACEBO_COMPARATOR

topical placebo tablet

Intervention Type: DRUG

Individuals will be instructed to dissolve half a tablet of placebo medication and hold the saliva near the painful oral sites without swallowing, for 3 minutes and then spit. Tablets will contain magnesium silicate, with the same color and flavor as the test medications. Researchers will provide a total of 32 tablets for each participant.

control

artificial saliva

Group Type: NO_INTERVENTION

No interventions assigned to this group

topical clonazepam tablet

2.0 mg Clonazepam tablet three times a day for 21 days

Group Type: EXPERIMENTAL

topical clonazepam tablet

Intervention Type: DRUG

Individuals will be instructed to dissolve half a tablet of clonazepam and hold the saliva near the painful oral sites without swallowing for 3 minutes and then spit. Researchers will provide a total of 32 tablets for each participant.

oral alpha-lipoic acid capsule

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

Group Type: EXPERIMENTAL

oral alpha-lipoic acid capsule

Intervention Type: DIETARY_SUPPLEMENT

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

topical phytotherapic capsaicin gel

0.025 mg capsaicin gel 4 times a day for 14 days

Group Type: EXPERIMENTAL

topical phytotherapic capsaicin gel

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

local photobiomodulation

Intervention Type: RADIATION

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.

Interventions

topical placebo tablet

Individuals will be instructed to dissolve half a tablet of placebo medication and hold the saliva near the painful oral sites without swallowing, for 3 minutes and then spit. Tablets will contain magnesium silicate, with the same color and flavor as the test medications. Researchers will provide a total of 32 tablets for each participant.

Intervention Type: DRUG

topical clonazepam tablet

Individuals will be instructed to dissolve half a tablet of clonazepam and hold the saliva near the painful oral sites without swallowing for 3 minutes and then spit. Researchers will provide a total of 32 tablets for each participant.

Intervention Type: DRUG

oral alpha-lipoic acid capsule

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

Intervention Type: DIETARY_SUPPLEMENT

topical phytotherapic capsaicin gel

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

Intervention Type: OTHER

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.

Intervention Type: RADIATION

Other Intervention Names

magnesium silicate; photodynamic therapy

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Fernando O Costa

Titular Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernando O Costa, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

Federal university of minas gerais

Belo Horizonte, Minas Gerais, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Fernando O Costa, PhD

Role: CONTACT

Phone: +55 31 9954-0657

Email: focperio@uol.com.br

Facility Contacts

Luis Cota, PhD

Role: primary

Other Identifiers

6.161.933

Identifier Type: -

Identifier Source: org_study_id