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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2022
Source University of Zagreb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Epworth's sleepiness scale; unstimulated saliva sample
Unstimulated saliva sample; Epworth's sleepiness scale

Locations

Country Name City State
Croatia School of Dental Medicine, University of Zagreb Zagreb

Sponsors (1)

Lead Sponsor Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

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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