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

A Randomized Controlled Trial Comparing the Efficacy of Photobiomodulation Therapy and Alpha-Lipoic Acid in the Treatment of Burning Mouth Syndrome

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Burning Mouth Syndrome; Low Level Laser Therapy
• Intervention / Treatment: Drug: Alpha Lipoic Acid; Other: Low Level Laser Therapy

Detailed Description

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Stomatology, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PBMT group; Burning mouth syndrome (BMS) patients in PBMT group were provided with BMS disease explanation and psychological counseling. They will receive low-energy laser therapy with an energy density of 5 J/cm² and a power of 0.1/0.5 W for a consecutive period of 2 weeks, 5 days per week.	Other: Low Level Laser Therapy; Energy density: 5 J/cm² Power: 0.1/0.5 W Course of treatment: 2 consecutive weeks, 5 days per week.; Other Names: LLLT; Photobiomodulation Therapy; PBMT
Active Comparator: ALA group; Burning mouth syndrome (BMS) patients in the ALA group were provided with BMS disease explanation and psychological counseling. Then they took α-lipoic acid (ALA) 3 times a day, after meals, 200 mg each time, for 2 consecutive weeks.	Drug: Alpha Lipoic Acid; Dosage: 600-800 mg ALA Course of treatment: 2 consecutive weeks, 3 times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 2 weeks after intervention or observation

Collaborators and Investigators

• Sponsor: Lu Jiang
• Investigators: Principal Investigator: Lu Jiang, MD, Sichuan University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2025
• Primary Completion (Actual): January 20, 2026
• Study Completion (Estimated): March 10, 2026

Study Registration Dates

• First Submitted: January 25, 2026
• First Submitted That Met QC Criteria: January 25, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Burning Mouth Syndrome; Sulfur Compounds; Organic Chemicals; Therapeutics; Fatty Acids; Lipids; Carboxylic Acids; Enzymes and Coenzymes; Coenzymes; Thiophenes; Laser Therapy; Phototherapy; Thioctic Acid; Low-Level Light Therapy
• Other Study ID Numbers: WCHSIRB-D-2025-189-R1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No