Melatonin to Treat Burning Mouth Syndrome (BMS): A Randomized, Cross-over, Placebo-controlled, Triple-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Reduction/resolution of symptoms in BMS
研究概览
简要总结
The purpose of this study is to determine whether melatonin is effective in the treatment of burning mouth syndrome (BMS).
详细描述
This is a crossover trial involving a total of 20 patients with Burning Mouth Syndrome, considered a chronic neuropathic pain. In two consecutive treatment periods, both 8 week long, each patient receives externally indistinguishable capsules (placebo or melatonin). A 4 weeks wash-out period is applied, between these two periods.
The capsules contain either placebo or 3 mg-melatonin (4 time/day for a total of 12 mg/day of melatonin). The primary endpoint is the change in pain intensity at the end of each treatment period, measured using VAS, verbal intensity score and NRS, as well as number of oral sites affected by the burning sensation. Furthermore, data from quality of life, anxiety and sleep questionnaires are collected (sf-36, HAM-A, ESS, MOS).
Adverse effects are carefully recorded as well as blood samples, in order to measure serum melatonin levels during the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients over 18 yrs suffering from burning mouth syndrome
排除标准
- •pregnancy
- •concomitant treatment with melatonin
- •concomitant anticoagulants
- •night time working persons
结局指标
主要结局
Reduction/resolution of symptoms in BMS
时间窗: within the first 60 days
次要结局
- improvement in quality of life(within the first 60 days)
研究者
ANDREA SARDELLA
Associate Professor of Oral Diseases
University of Milan