COMPARATIVE ANALYSIS OF PHOTOBIOMODULATION THERAPY AND CAPSAICIN MOUTHWASH IN THE TREATMENT OF BURNING MOUTH: A RANDOMIZED CLINICAL TRIAL
burning mouth; treatment; photobiomodulatory therapy; capsaicin
Introduction: Burning mouth is characterized by a burning sensation in the oral mucosa that recurs for more than two hours a day, on 50% of days for more than three months, in the absence of associated local factors. It has an uncertain etiology and difficult management of painful symptoms, since several treatments are proposed, but there is still no consensus on which would be the most efficient. Objective: To evaluate and compare the efficacy of photobiomodulatory therapy and topical capsaicin in the management of burning mouth, through the evaluation of painful symptoms and unstimulated salivary flow, before and after treatment. Material and methods: This is prospective, a randomized clinical trial that will follow the CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study population will consist of patients presenting with complaints of burning mouth treated at the Stomatology Service of the Department of Dentistry (DOD) at UFRN. Individuals of both sexes, over 18 years of age, who present a burning sensation in the oral mucosa according to the criteria of the International Classification of Headache Disorders (IHS) will be included in the study. Patients will be randomly assigned to one of the three study groups: photobiomodulatory therapy, 0.001% aqueous solution of capsaicin for mouthwash, and combination of photobiomodulatory therapy with capsaicin mouthwash. Data such as age, sex, skin color, profession, as well as previous medical history will be collected. Laboratory tests will be requested to investigate chronic diseases, blood disorders, nutritional and hormonal deficiencies and immunological alterations that may be related to the burning mouth. The analysis of symptoms will be performed using the Visual Analogue Pain Scale (VAS) consisting of a 10 cm line marked with values from 0 (absence of painful symptoms) to 10 (most intense pain experienced). The analysis of symptoms will be assessed at four time points: before starting treatment, after 15 days, after 30 days (at the end of treatment) and 30 days after the end of treatment. The quantitative evaluation of saliva will be performed by collecting unstimulated salivary flow before and after treatment. Patients with an unstimulated salivary flow rate <0.1 mL/min will be classified as having hyposalivation. Data will be analyzed using descriptive statistics and appropriate inferential tests to compare the three groups and the different evaluation time points, considering a significance level of 5%. For continuous variables, repeated measures ANOVA or equivalent non-parametric tests will be applied, depending on data distribution