Burning Mouth SyndromeNCT07381361
Photobiomodulation Therapy vs. Alpha-Lipoic Acid in Burning Mouth Syndrome Treatment
A study testing Low Level Laser Therapy and Alpha Lipoic Acid in people with Burning Mouth Syndrome and Low Level Laser Therapy, run by Lu Jiang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Burning Mouth Syndrome, Low Level Laser Therapy
- What is being tested?
- Low Level Laser Therapy and Alpha Lipoic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 10 Mar 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
West China Hospital of Stomatology, Sichuan University
Chengdu, Sichuan, 610041
About this study
Official title: 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.
Read the 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.
- Conditions
- Burning Mouth Syndrome, Low Level Laser Therapy
- Being tested
- Low Level Laser Therapy, Alpha Lipoic Acid
- Medical subject headings
- Burning Mouth Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyOther
Also called PBMT, LLLT, Photobiomodulation Therapy
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Alpha Lipoic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 2 weeks after intervention or observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start10 Apr 2025
- Primary completion20 Jan 2026
- Study completion10 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burning Mouth SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lu Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lu Jiang, Sichuan University
- Investigators
- Lu Jiang, MD, Principal investigator, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381361
- Sponsor's protocol ID
- WCHSIRB-D-2025-189-R1
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No