BruxismNCT06623643
"Salivary Melatonin and Cortisol Levels in Individuals with Bruxism"
An observational study of Bruxism, run by Yuzuncu Yil University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bruxism
- What is being tested?
- The investigation of melatonin and cortisol levels in the saliva
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2024to 28 Feb 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ndividuals with and without bruxism
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Bruxism
- Being tested
- The investigation of melatonin and cortisol levels in the saliva
- Keywords
- melatonin, saliva, cortizol
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The investigation of melatonin and cortisol levels in the salivaDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Evaluation of Melatonin and Cortisol Levels in Individuals with Bruxism Receives: Diagnostic Test: The investigation of melatonin and cortisol levels in the saliva | |
| 2 | Evaluation of Melatonin and Cortisol Levels in Individuals without Bruxism Receives: Diagnostic Test: The investigation of melatonin and cortisol levels in the saliva |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of melatonin
individuals with bruxism
Measured: 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
Measured: Baseline assessment at the start of the study, follow-up assessments at 3 months and 6 months, with final data collection at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start30 Oct 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sema kaya, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623643
- Sponsor's protocol ID
- 2024-10-31
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Melatonin and Cortisol Levels in the Saliva of Individuals with Bruxism
- ClinicalTrials.gov ID
- NCT06623643
- Acronym / sponsor ID
- 2024-10-31
- Conditions
- Bruxism
- Keywords
- melatonin, saliva, cortizol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: The investigation of melatonin and cortisol levels in the salivaEvaluation of Melatonin and Cortisol Levels in Individuals with Bruxism |
| 2 | – | Diagnostic Test: The investigation of melatonin and cortisol levels in the salivaEvaluation of Melatonin and Cortisol Levels in Individuals without Bruxism |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ndividuals with and without bruxism
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The investigation of melatonin and cortisol levels in the salivaIn 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. | Diagnostic test | 1, 2 |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Bruxism, run by Yuzuncu Yil University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sema Kaya (+90 432 225 17 22 ext. +905540062682, semakaya@yyu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.