Clinical trial NCT06040190: Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Burning Mouth Syndrome
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Change in pain scores
timeFrame: baseline and 3 weeks
measure: Change in pain scores
timeFrame: baseline and 2 months
Secondary outcomes:
measure: Change in quality of life scores
timeFrame: baseline and 3 weeks
measure: Change in quality of life scores
timeFrame: baseline and 2 months
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal university of minas gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Fernando O Costa, PhD
role: PRINCIPAL_INVESTIGATOR
References: