"Salivary Melatonin and Cortisol Levels in Individuals with Bruxism"

The Investigation of Melatonin and Cortisol Levels in the Saliva of 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bruxism
• Intervention / Treatment: Diagnostic test: The investigation of melatonin and cortisol levels in the saliva

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Sema Kaya; Phone Number: +905540062682 +90 432 225 17 22; Email: semakaya@yyu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

ndividuals with and without bruxism

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Evaluation of Melatonin and Cortisol Levels in Individuals with Bruxism	Diagnostic test: The investigation of melatonin and cortisol levels in the saliva; 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.
2; Evaluation of Melatonin and Cortisol Levels in Individuals without Bruxism	Diagnostic test: The investigation of melatonin and cortisol levels in the saliva; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
levels of melatonin	individuals with bruxism	Baseline assessment at the start of the study, follow-up assessments at 3 months and 6 months, with final data collection at 12 months.
levels of cortisol	individuals with bruxism	Baseline assessment at the start of the study, follow-up assessments at 3 months and 6 months, with final data collection at 12 months.

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: melatonin; saliva; cortizol
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Bruxism; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anti-Inflammatory Agents; Protective Agents; Antioxidants; Melatonin; Hydrocortisone
• Other Study ID Numbers: 2024-10-31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No