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

PHASE4RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

November 1, 2023

Primary Completion Date

July 1, 2025

Study Completion Date

October 1, 2025

Conditions
Burning Mouth Syndrome
Interventions
DRUG

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.

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.

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.

Trial Locations (1)

Unknown

RECRUITING

Federal university of minas gerais, Belo Horizonte

All Listed Sponsors
lead

Federal University of Minas Gerais

OTHER