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

Burning Mouth Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05309681
• Other study ID #: 09/2020
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Burning Mouth Syndrome
• Burns
• Melatonin
• Syndrome

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