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

Sponsor
University of Zagreb (Other)
Overall Status
Completed
CT.gov ID
NCT05309681
Collaborator
(none)
45
1
11.2
4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Epworth's sleepiness scale; unstimulated saliva sample

Study Design

Study Type:
Observational
Actual Enrollment :
45 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Salivary Melatonin Levels and Sleep Quality in Patients With Burning Mouth Syndrome
Actual Study Start Date :
Jan 7, 2021
Actual Primary Completion Date :
Jul 18, 2021
Actual Study Completion Date :
Dec 15, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:
  • female patients

  • primary burning mouth syndrome

  • without oral lesions

Exclusion Criteria:
  • secondary burning mouth syndrome

  • male gender

  • patients with oral lesions

Contacts and Locations

Locations

Site City State Country Postal Code
1 School of Dental Medicine, University of Zagreb Zagreb Croatia 10000

Sponsors and Collaborators

  • University of Zagreb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Božana Lončar Brzak, Assistant Professor at the Department of Oral Medicine, University of Zagreb
ClinicalTrials.gov Identifier:
NCT05309681
Other Study ID Numbers:
  • 09/2020
First Posted:
Apr 4, 2022
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2022