Photobiomodulation Therapy vs. Alpha-Lipoic Acid in Burning Mouth Syndrome Treatment

N/AActive Not RecruitingNCT07381361

Lu Jiang60 enrolled

Overview

The aim of this study was to evaluate the efficacy of photobiomodulation therapy and alpha-lipoic acid in the treatment of burning mouth syndrome by symptom assessment with visual analogue scale.

Burning mouth syndrome (BMS), hereinafter referred to as BMS, also known as glossodynia, oral mucosal dysesthesia, and other terms, is a type of neurosis. Its prevalence is approximately 0.7%-8%. Currently, the etiology and pathophysiology of BMS are not yet clear, and there is no known cure. Clinical treatment aims to alleviate patients' subjective symptoms, employing drug therapies (such as rinsing with 2%-4% sodium bicarbonate solution, oryzanol, methylcobalamin, alpha-lipoic acid, etc.), or combining cognitive behavioral therapy and removal of local irritants (such as dental calculus), but the therapeutic effects are limited. Photobiomodulation therapy (PBMT), also known as low-level laser therapy (LLLT), is a therapeutic method that induces a series of physiological effects in cells, tissues, animals, and humans through the irradiation of specific wavelengths of red or near-infrared light. Research indicates that PBMT can alleviate the pain intensity in patients with BMS through its photobiological effects. Research has shown that photobiomodulation therapy can alleviate the pain of patients with burning mouth syndrome through photobiological effects. Therefore, this research project primarily investigates the efficacy of PBMT for BMS and the differences in therapeutic effects under different parameter settings by establishing a controlled trial with a low-energy laser treatment group and an alpha-lipoic acid control group. Based on the results of the clinical trial, this therapy is intended to be promoted.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Burning Mouth Syndrome Low Level Laser Therapy

Interventions

Low Level Laser TherapyOTHER

Energy density: 5 J/cm² Power: 0.1/0.5 W Course of treatment: 2 consecutive weeks, 5 days per week.

Alpha Lipoic AcidDRUG

Dosage: 600-800 mg ALA Course of treatment: 2 consecutive weeks, 3 times per day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged 18 to 75 years * Diagnosis of Burning Mouth Syndrome (BMS) according to the 3rd edition of the International Classification of Headache Disorders (ICHD-3) * Daily intraoral burning or dysesthesia lasting for more than 2 hours for over 3 months * Normal oral mucosa and sensory testing * Condition not better accounted for by another ICHD-3 diagnosis Exclusion Criteria: * Other oral mucosal diseases, such as oral leukoplakia or oral lichen planus * Diabetes with poor blood glucose control * Hematological diseases * Pregnancy or lactation * Severe mental disorders preventing cooperation with treatment * Heart failure (New York Heart Association class III-IV)

Locations (1)

West China Hospital of Stomatology, Sichuan University

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

Visual Analogue Scale (VAS)

The Visual Analogue Scale (VAS) will be used to assess the intensity of the patient's pain. The scale ranges from 0 to 10, where 0 represents "no pain" (the best possible outcome) and 10 represents "the worst pain imaginable" (the worst possible outcome). Therefore, higher scores indicate a worse outcome (greater pain intensity). During the interview or telephone follow-up, the patient will be asked to report the number that best describes their pain.

Time frame: Baseline and 2 weeks after intervention or observation

Data from ClinicalTrials.gov

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