"Salivary Melatonin and Cortisol Levels in Individuals with Bruxism"

NCT06623643 | Not Yet Recruiting

• 1 other identifier: 2024-10-31
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bruxism

Keywords

melatonin; saliva; cortizol

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

1

Evaluation of Melatonin and Cortisol Levels in Individuals with Bruxism

Diagnostic Test: The investigation of melatonin and cortisol levels in the saliva

2

Evaluation of Melatonin and Cortisol Levels in Individuals without Bruxism

Diagnostic Test: The investigation of melatonin and cortisol levels in the saliva

Interventions

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.

1; 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ndividuals with and without bruxism

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Biospecimen

Retention: SAMPLES WITH DNA

The melatonin and cortisol levels in the saliva of patients will be examined. Since saliva will be collected, it contains DNA. However, it will not be used for research purposes.

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Central Study Contacts

Sema Kaya

CONTACT

+90 432 225 17 22; semakaya@yyu.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 2, 2024
• Study Start: October 30, 2024
• Primary Completion: December 30, 2024
• Study Completion: February 28, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-10