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

NCT06040190 | Recruiting Phase 4 DMC

• 1 other identifier: 6.161.933
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Change in quality of life scores

  baseline and 3 weeks

• Change in quality of life scores

  baseline and 2 months

Study Arms (6)

topical placebo tablet

PLACEBO COMPARATOR

magnesium silicate placebo tablet three times a day for 21 days

Drug: topical placebo tablet

control

NO INTERVENTION

artificial saliva

topical clonazepam tablet

EXPERIMENTAL

2.0 mg Clonazepam tablet three times a day for 21 days

Drug: topical clonazepam tablet

oral alpha-lipoic acid capsule

EXPERIMENTAL

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

Dietary Supplement: oral alpha-lipoic acid capsule

topical phytotherapic capsaicin gel

EXPERIMENTAL

0.025 mg capsaicin gel 4 times a day for 14 days

Other: topical phytotherapic capsaicin gel

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.

Radiation: local photobiomodulation

Interventions

topical placebo tablet 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.

Also known as: magnesium silicate

topical placebo tablet

topical clonazepam tablet 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.

topical clonazepam tablet

oral alpha-lipoic acid capsule DIETARY_SUPPLEMENT

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

oral alpha-lipoic acid capsule

topical phytotherapic capsaicin gel OTHER

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

topical phytotherapic capsaicin gel

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.

Also known as: photodynamic therapy

local photobiomodulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Federal university of minas gerais

Belo Horizonte, Minas Gerais, Brazil

RECRUITING

MeSH Terms

Conditions

Burning Mouth Syndrome

Interventions

Florisil; Clonazepam; Thioctic Acid; Photochemotherapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Fernando O Costa, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando O Costa, PhD

CONTACT

+55 31 9954-0657; focperio@uol.com.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Titular Professor

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 15, 2023
• Study Start: November 1, 2023
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)