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

NCT07381361 | Active Not Recruiting

• 1 other identifier: WCHSIRB-D-2025-189-R1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Burning Mouth Syndrome; Low Level Laser Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

PBMT group

EXPERIMENTAL

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

ALA group

ACTIVE COMPARATOR

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

Interventions

Low Level Laser Therapy OTHER

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

Also known as: PBMT, LLLT, Photobiomodulation Therapy

PBMT group

Alpha Lipoic Acid DRUG

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

ALA group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lu Jiang: lead

Study Sites (1)

West China Hospital of Stomatology, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Burning Mouth Syndrome

Interventions

Low-Level Light Therapy; Thioctic Acid

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Lu Jiang, MD

  Sichuan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 2, 2026
• Study Start: April 10, 2025
• Primary Completion: January 20, 2026
• Study Completion: March 10, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)