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NCT Number: NCT06623643

"Salivary Melatonin and Cortisol Levels in Individuals with Bruxism"

The effects of the hormones melatonin and cortisol, which play a highly effective role in regulating the sleep-wake cycle, on teeth grinding will be scientifically evaluated. Based on the research results, more effective methods for treating patients suffering from bruxism may be identified.

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Key information

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Individuals without any known hormonal diseases, not using antidepressants or medications that could alter saliva content, without degenerative diseases affecting the salivary glands, without cysts or tumors affecting the temporomandibular region, and not undergoing insomnia treatment will be included in the study

Exclusion criteria

  • Individuals with systemic diseases that affect or may potentially affect saliva content, or those using medications that cause these effects, will not be included in the study

Treatment and study plan

The investigation of melatonin and cortisol levels in the saliva

Diagnostic Test

In the related study, patient data from individuals who visited the Oral and Maxillofacial Radiology clinic at Van Yüzüncü Yıl University Faculty of Dentistry with complaints of bruxism will be used. The diagnosis of bruxism will be made based on clinical data. Diagnoses will be made by Dr. Sema KAYA using clinical findings such as patient history used for the current diagnosis of bruxism, tooth wear, tooth mobility, pain in the temporomandibular joint (TMJ), headaches, pain in the chewing muscles, hypertrophy, and a feeling of fatigue. Before taking the saliva samples, patients will be asked to rinse their mouths with sterile water, and then they will be asked to spit into sterile plastic containers. After approximately 3 mL of saliva is collected, it will be transferred to appropriate Eppendorf tubes and stored at -80°C. Melatonin and cortisol levels will later be analyzed using the enzyme-linked immunosorbent assay (ELISA) method.

Primary outcomes

  1. levels of melatonin

    Time frame: Baseline assessment at the start of the study, follow-up assessments at 3 months and 6 months, with final data collection at 12 months.

    individuals with bruxism

  2. levels of cortisol

    Time frame: Baseline assessment at the start of the study, follow-up assessments at 3 months and 6 months, with final data collection at 12 months.

    individuals with bruxism

Study contacts

Contact information is provided by the study sponsor or research team.

Sema Kaya

CONTACT

[email protected]

+90 432 225 17 22 ext. +905540062682

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

The Investigation of Melatonin and Cortisol Levels in the Saliva of Individuals with Bruxism

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 2, 2024
Registry last updated
Oct 4, 2024

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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