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

Phase 4

Recruiting

• Conditions: Burning Mouth Syndrome
• Interventions: Dietary Supplement: oral alpha-lipoic acid capsule; Radiation: local photobiomodulation; Drug: topical placebo tablet; Other: topical phytotherapic capsaicin gel; Drug: topical clonazepam tablet

• Registration Number: NCT06040190
• Lead Sponsor: Federal University of Minas Gerais

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-10
• Study First Submitted QC: 2023-09-10
• Study First Posted: 2023-09-15
• Study Start: 2023-11-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-07-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral alpha-lipoic acid capsule	oral alpha-lipoic acid capsule	300 mg alpha-lipoic acid capsule twice a day for 60 days
local photobiomodulation	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.
topical placebo tablet	topical placebo tablet	magnesium silicate placebo tablet three times a day for 21 days
topical phytotherapic capsaicin gel	topical phytotherapic capsaicin gel	0.025 mg capsaicin gel 4 times a day for 14 days
topical clonazepam tablet	topical clonazepam tablet	2.0 mg Clonazepam tablet three times a day for 21 days

Primary Outcome Measures

Name	Time	Method
Change in pain scores	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 Outcome Measures

Name	Time	Method
Change in quality of life scores	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).

Trial Locations

Locations (1)

Federal university of minas gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil