A Randomized Controlled Trial Comparing the Efficacy of Photobiomodulation Therapy and Alpha-Lipoic Acid in the Treatment of Burning Mouth Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Low Level Laser Therapy (Other)
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.
干预措施: Alpha Lipoic Acid (Drug)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: Baseline and 2 weeks after intervention or observation
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.
次要结局
未报告次要终点
研究者
Lu Jiang
Clinical Professor
Sichuan University