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

Burning Mouth Syndrome Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06040190
• Other study ID #: 6.161.933
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: Federal University of Minas Gerais
• Contact: Fernando O Costa, PhD
• Phone: +55 31 9954-0657
• Email: focperio[@]uol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Burning Mouth Syndrome
• Burns
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal university of minas gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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