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

Completed

• Conditions: Melatonin; Burning Mouth Syndrome
• Interventions: Other: Epworth's sleepiness scale; unstimulated saliva sample

• Registration Number: NCT05309681
• Lead Sponsor: University of Zagreb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-07
• Primary Completion: 2021-07-18
• Study Completion: 2021-12-15
• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-04-04
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Epworth's sleepiness scale; unstimulated saliva sample	Female patients of the Department of Oral medicine diagnosed with burning mouth syndrome
Control group	Epworth's sleepiness scale; unstimulated saliva sample	Age-matched female patients without oral lesions and without burning mouth syndrome

Primary Outcome Measures

Name	Time	Method
determining the level of salivary melatonin	January 2021-July 2021	The level of salivary melatonin will be determined in frozen samples of unstimulated saliva samples

Secondary Outcome Measures

Name	Time	Method
determining the difference in Epworth's sleepiness scale	January 2021-July 2021	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.

Trial Locations

Locations (1)

School of Dental Medicine, University of Zagreb; 🇭🇷 Zagreb, Croatia