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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05309681
Enrollment
45
Registered
2022-04-04
Start date
2021-01-07
Completion date
2021-12-15
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burning Mouth Syndrome, Melatonin

Brief 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.

Interventions

OTHEREpworth's sleepiness scale; unstimulated saliva sample

Unstimulated saliva sample; Epworth's sleepiness scale

Sponsors

University of Zagreb
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years

Inclusion criteria

* female patients * primary burning mouth syndrome * without oral lesions

Exclusion criteria

* secondary burning mouth syndrome * male gender * patients with oral lesions

Design outcomes

Primary

MeasureTime frameDescription
determining the level of salivary melatoninJanuary 2021-July 2021The level of salivary melatonin will be determined in frozen samples of unstimulated saliva samples

Secondary

MeasureTime frameDescription
determining the difference in Epworth's sleepiness scaleJanuary 2021-July 2021The 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.

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026