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

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.

Study Overview

• Status: Completed
• Conditions: Melatonin; Burning Mouth Syndrome
• Intervention / Treatment: Other: Epworth's sleepiness scale; unstimulated saliva sample

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • School of Dental Medicine, University of Zagreb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female patients with burning mouth syndrome and age-matched female controls without burning mouth syndrome or oral lesions will be included in the study. A sample of unstimulated saliva will be taken from all patients and frozen. All patients will also fill in Epworth's sleepiness scale.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Zagreb

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2021
• Primary Completion (Actual): July 18, 2021
• Study Completion (Actual): December 15, 2021

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Stomatognathic Diseases; Mouth Diseases; Syndrome; Burns; Burning Mouth Syndrome
• Other Study ID Numbers: 09/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No