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

NCT05309681 | Completed

• 1 other identifier: 09/2020
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Burning Mouth Syndrome; Melatonin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• determining the difference in Epworth's sleepiness scale

  January 2021-July 2021

Study Arms (2)

Study group

Female patients of the Department of Oral medicine diagnosed with burning mouth syndrome

Other: Epworth's sleepiness scale; unstimulated saliva sample

Control group

Age-matched female patients without oral lesions and without burning mouth syndrome

Other: Epworth's sleepiness scale; unstimulated saliva sample

Interventions

Epworth's sleepiness scale; unstimulated saliva sample OTHER

Unstimulated saliva sample; Epworth's sleepiness scale

Control group; Study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

School of Dental Medicine, University of Zagreb

Zagreb, 10000, Croatia

Location

Biospecimen

Retention: SAMPLES WITH DNA

unstimulated saliva samples

MeSH Terms

Conditions

Burning Mouth Syndrome

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor at the Department of Oral Medicine

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 4, 2022
• Study Start: January 7, 2021
• Primary Completion: July 18, 2021
• Study Completion: December 15, 2021
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)