Sleep Disorders, Circadian Rhythm
Conditions
Keywords
Burning mouth syndrome,, melatonin, pain, sleep
Brief summary
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.
Detailed description
The purpose of this study is to establish whether melatonin can aid in reducing pain improve sleep quality in (BMS)
Interventions
DRUGMelatonin 3 mg
1 time a day for 8 weeks
DRUGPlacebo Oral
1 time a day for 8 weeks
Sponsors
Universidad de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Intraoral burning or dysaesthetic sensation, recurring daily for more than 2 hours per day over more than 3 months, without clinically evident causative lesions
Exclusion criteria
* Previous or current therapy with melatonin * Allergy or hypersensitivity to melatonin * Less than 18 years old. * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Questionnaire | day 0 .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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral Pain | day 0 .Pain was scored using a Visual Analogue Scale (VAS) (with a score of 1-10: 0 = no pain, 10 = extreme pain) | Visual Analogue Scale (VAS) |
| Questionnaire ORAL Quality of life | day 0 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. | Questionnaire OHIP 14 Oral quality of life |
Countries
Spain
Contacts
Primary ContactLopez-Jornet Pia, PhD
Outcome results
None listed