Burning Mouth Syndrome Clinical Trial
Official title:
Salivary Melatonin Levels and Sleep Quality in Patients With Burning Mouth Syndrome
NCT number | NCT05309681 |
Other study ID # | 09/2020 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 7, 2021 |
Est. completion date | December 15, 2021 |
Verified date | May 2022 |
Source | University of Zagreb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | December 15, 2021 |
Est. primary completion date | July 18, 2021 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - female patients - primary burning mouth syndrome - without oral lesions Exclusion Criteria: - secondary burning mouth syndrome - male gender - patients with oral lesions |
Country | Name | City | State |
---|---|---|---|
Croatia | School of Dental Medicine, University of Zagreb | Zagreb |
Lead Sponsor | Collaborator |
---|---|
University of Zagreb |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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