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Completed

NCT Number: NCT05309681

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.

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Key information

Conditions

Burning Mouth Syndrome Melatonin Mouth Diseases Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

School of Dental Medicine, University of Zagreb

Zagreb, 10000, Croatia

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Epworth's sleepiness scale; unstimulated saliva sample

Other

Unstimulated saliva sample; Epworth's sleepiness scale

Primary outcomes

  1. determining the level of salivary melatonin

    Time frame: January 2021-July 2021

    The level of salivary melatonin will be determined in frozen samples of unstimulated saliva samples

Secondary outcomes

  1. determining the difference in Epworth's sleepiness scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 4, 2022
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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