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

NCT ID: NCT05309681

Last Updated: 2022-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-07

Study Completion Date

2021-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Burning Mouth Syndrome Melatonin

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Study group

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

Epworth's sleepiness scale; unstimulated saliva sample

Intervention Type OTHER

Unstimulated saliva sample; Epworth's sleepiness scale

Control group

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

Epworth's sleepiness scale; unstimulated saliva sample

Intervention Type OTHER

Unstimulated saliva sample; Epworth's sleepiness scale

Interventions

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Epworth's sleepiness scale; unstimulated saliva sample

Unstimulated saliva sample; Epworth's sleepiness scale

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* secondary burning mouth syndrome
* male gender
* patients with oral lesions
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Zagreb

OTHER

Sponsor Role lead

Responsible Party

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Božana Lončar Brzak

Assistant Professor at the Department of Oral Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of Dental Medicine, University of Zagreb

Zagreb, , Croatia

Site Status

Countries

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Croatia

Other Identifiers

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09/2020

Identifier Type: -

Identifier Source: org_study_id

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