Study of the Efficacy of Melatonin in the Burning Mouth Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Sleep Questionnaire
研究概览
简要总结
Burning mouth ( BMS) syndrome is the oral disorder characterized by an intraoral burning sensation for which no medical or dental cause can be found. The Headache Classification Committee of the International Headache Society (IHS) defines (BMS) as an ''intraoral burning or dysaesthetic sensation, recurring daily for more than 2 hours per day over more than 3 months, without clinically evident causative lesions''. (BMS) is a common, chronic problem that has a negative impact on quality of life.
A wide variety of medications have been proposed for treating (BMS) both topical and systemic. Unfortunately, no treatment seems to offer assured results. Melatonin is a naturally occurring hormone secreted by the pineal gland. It has soporific effects with oral administration and is well tolerated. It enhances sleep Melatonin also may help sleep disturbances associated with (BMS) ; however, this remains to be proven.
详细描述
The purpose of this study is to establish whether melatonin can aid in reducing pain improve sleep quality in (BMS)
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
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Intraoral burning or dysaesthetic sensation, recurring daily for more than 2 hours per day over more than 3 months, without clinically evident causative lesions
排除标准
- •Previous or current therapy with melatonin
- •Allergy or hypersensitivity to melatonin
- •Less than 18 years old.
研究组 & 干预措施
Melatonin
Melatonin ORAL FILM 3mg will be taken by the subject once a day for 8 weeks
干预措施: Melatonin 3 mg (Drug)
placebo
ORAL FILM 3mg placebo will be taken by the subject once a day for 8 weeks
干预措施: Placebo Oral (Drug)
结局指标
主要结局
Sleep Questionnaire
时间窗: 8 weeks.The PSQI total score ranges from 0 to 21 with 0 being marvelous sleep and 21 being horrid sleep. The difference score, reported below, is the total score after at least 8 weeks of treatment. A negative score means that the sleep
The Pittsburgh Sleep Quality Index (PSQI)
次要结局
- Oral Pain(8 weeks.Pain was scored using a Visual Analogue Scale (VAS) (with a score of 1-10: 0 = no pain, 10 = extreme pain))
- Questionnaire ORAL Quality of life(8 weeks The instrument consists of 14 items that explore different aspects of oral function and quality of life. The score ranges from 0 to 70, with higher scores corresponding to poorer oral quality of life.)
研究者
Pia Lopez Jornet
Head of Oral Medicine
Universidad de Murcia