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NCT Number: NCT06040190

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

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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Key information

Conditions

Burning Mouth Syndrome Mouth Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Federal university of minas gerais

Belo Horizonte, Minas Gerais, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

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.

Other names: photodynamic therapy

Primary outcomes

  1. Change in pain scores

    Time frame: baseline and 3 weeks

    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.

  2. Change in pain scores

    Time frame: baseline and 2 months

    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.

Secondary outcomes

  1. Change in quality of life scores

    Time frame: baseline and 3 weeks

    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).

  2. Change in quality of life scores

    Time frame: baseline and 2 months

    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).

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

Evaluation of the Effect of Different Treatments on Pain Scores and Self-reported Oral Health-related Quality of Life in Individuals With Burning Mouth Syndrome: a Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2023
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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