Salivary Melatonin Levels and Sleep Quality in Patients With Burning Mouth Syndrome

Study Overview
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Brief Summary
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Burning mouth syndrome is an idiopathic condition characterized by symptoms burning and / or pain of the oral mucosa with an orderly clinical finding. So far not found a unique way of treatment. It is a diagnosis that impairs the quality of life of patients, and consequently it can affect the quality of sleep. Melatonin is a hormone secreted from pineal gland and regulates the day-night rhythm of man, and whose production in the body decreases aging. The level of melatonin in saliva correlates well with the level of melatonin in plasma, therefore they are advantages of determining from saliva painlessness and non-invasiveness of the procedure itself. The purpose of this study was to compare the level of melatonin in saliva and the quality of sleep with help of the Epworth Sleepiness Scale in patients with burning mouth syndrome and control groups of patients without subjective oral disorders and with an orderly clinical finding.

Official Title
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Salivary Melatonin Levels and Sleep Quality in Patients With Burning Mouth Syndrome

Conditions
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Burning Mouth Syndrome, Melatonin

Intervention / Treatment
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* Other: Epworth's sleepiness scale; unstimulated saliva sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female patients primary burning mouth syndrome without oral lesions Exclusion Criteria: secondary burning mouth syndrome male gender patients with oral lesions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Female patients of the Department of Oral medicine diagnosed with burning mouth syndrome | Other: Epworth's sleepiness scale; unstimulated saliva sample<br>* Unstimulated saliva sample; Epworth's sleepiness scale<br>|
| Control group<br>Age-matched female patients without oral lesions and without burning mouth syndrome | Other: Epworth's sleepiness scale; unstimulated saliva sample<br>* Unstimulated saliva sample; Epworth's sleepiness scale<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determining the level of salivary melatonin | The level of salivary melatonin will be determined in frozen samples of unstimulated saliva samples | January 2021-July 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determining the difference in Epworth's sleepiness scale | The test is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. Total score is graded from 0-24. 0-7:It is unlikely that you are abnormally sleepy. 8-9:You have an average amount of daytime sleepiness. 10-15:You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24:You are excessively sleepy and should consider seeking medical attention. | January 2021-July 2021 |