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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topical placebo tablet | Placebo Comparator | magnesium silicate placebo tablet three times a day for 21 days |
|
| control | No Intervention | artificial saliva | |
| topical clonazepam tablet | Experimental | 2.0 mg Clonazepam tablet three times a day for 21 days |
|
| oral alpha-lipoic acid capsule | Experimental | 300 mg alpha-lipoic acid capsule twice a day for 60 days |
|
| topical phytotherapic capsaicin gel | Experimental | 0.025 mg capsaicin gel 4 times a day for 14 days |
|
| local photobiomodulation | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| topical placebo rinse | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain scores | Change in pain scores measured by a visual analog scale and the short version of the McGill Pain Questionnaire. Visual Analogue Scale: values ranging from 0 (no pain) to 10 (most severe pain). The McGill instrument contains 15 descriptors of pain sensation (11 sensory and 4 affective), with each descriptor ranked on a 4-point rating scale (0 = none, 1 = mild, 2 = moderate and 3 = severe). Three measures of pain experience based on sensory and affective descriptors can be obtained: (1) The total index consists of the sum of all 15 descriptors with the total score ranging from 0 to 45; (2) The sensory index consists of the sum of descriptors 1 - 11 with the total score ranging from 0 to 33; and (3) the affective index consists of the sum of descriptors 12 - 15 with the total score ranging from 0 to 12. | baseline and 3 weeks |
| Change in pain scores | Change in pain scores measured by a visual analog scale and the short version of the McGill Pain Questionnaire. Visual Analogue Scale: values ranging from 0 (no pain) to 10 (most severe pain). The McGill instrument contains 15 descriptors of pain sensation (11 sensory and 4 affective), with each descriptor ranked on a 4-point rating scale (0 = none, 1 = mild, 2 = moderate and 3 = severe). Three measures of pain experience based on sensory and affective descriptors can be obtained: (1) The total index consists of the sum of all 15 descriptors with the total score ranging from 0 to 45; (2) The sensory index consists of the sum of descriptors 1 - 11 with the total score ranging from 0 to 33; and (3) the affective index consists of the sum of descriptors 12 - 15 with the total score ranging from 0 to 12. | baseline and 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life scores | Change in quality of life measured by Oral Impacts on Daily Performance scores. Total score ranging from 0 to 275 being classified as: 0 = no impact, values 1 to 10 = low impact, values 11 to 40 = medium impact and values 41 to 275 = high impact (i.e, worse quality of life). | baseline and 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando O Costa, PhD | Federal University of Minas Gerais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal university of minas gerais | Belo Horizonte | Minas Gerais | Brazil |
Individual patient data will not be shared.
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| topical clonazepam rinse | Drug | 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 | Dietary Supplement | Participants in this group will be instructed to take oral capsules containing alpha-lipoic acid. |
|
| topical phytotherapic capsaicin gel | Other | Participants in this group will to apply the gel containing tocapsaicin on painful oral sites. |
|
| local photobiomodulation | 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. |
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| Change in quality of life scores |
Change in quality of life measured by Oral Impacts on Daily Performance scores. Total score ranging from 0 to 275 being classified as: 0 = no impact, values 1 to 10 = low impact, values 11 to 40 = medium impact and values 41 to 275 = high impact (i.e, worse quality of life). |
| baseline and 2 months |
| ID | Term |
|---|---|
| D002054 | Burning Mouth Syndrome |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| D010778 | Photochemotherapy |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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