- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05760482
Evaluation of the Relationship Between Bruxism and Tryptophan Metabolites
Study Overview
Status
Intervention / Treatment
Detailed Description
Bruxism is a common health problem that occurs throughout life and has a prevalence of 9% to 31% among adults. This common muscle disorder, characterized by teeth grinding or clamping, which can occur during sleep or day, is considered multifactorial with potential effects on the central nervous system. A possible relationship between mental health and bruxism has been investigated due to the indication of psychological factors such as anxiety and stress at the onset of bruxism. It has been reported that when the presence of mental disorders causes changes in the regulation of the central nervous system, they can act as a trigger point for bruxism.
Depression and anxiety disorders are the most common mental disorders studied and are expected to be the most common chronic condition by 2050. The emerging field of nutritional psychiatry offers some opportunities for clinical intervention for individuals suffering from depression and anxiety. L-tryptophan, a precursor of serotonin, is expected to contribute to the correction of depressive and anxious moods.
The primary catabolic pathway of tryptophan is the pathway of kynurenine, which is responsible for about 95-99% of tryptophan metabolism in the body. Tryptophan turns into kynurenine in the kynurenine pathway and is divided into two pathways. The first forms kynurenic acid, while the other forms 3-hydroxykynurenine (3-HK), 3-hydroxyanthranylic acid (3-HAA), and quinolinic acid (QA), respectively. The first pathway is considered neuroprotective, while the second pathway is known as neurotoxic.
In studies trying to explain the link between tryptophan and its metabolites and depression, they have emphasized that depression is caused by an imbalance in the kynurenine pathway and that the amount of quinolinic acid, which is neurotoxic, increases, while peripheral kynurenine, which is neuroprotective, decreases. It has been shown that the neurotoxic metabolites formed in the kynurenine itself and its pathway may be associated with depression and anxiety. There are researchers who think that changes in these parameters and their proportions to each other indicate different psychological states.
Changes in serum levels of these metabolites in cases of stress and anxiety have been supported by the studies mentioned above. Although most authorities assume that bruxism is based on psychological factors, the studies supporting them are usually anxiety and stress-focused survey studies based on subjective data. This assumption; researchers could not find a study comparing it with objective data. This study aims to present a possible relationship between bruxism and tryptophan metabolites in volunteer individuals with and without bruxism. The researchers' initial hypothesis is that "Changes in tryptophan and catabolites play a role in the etiology of bruxism."
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selçuklu
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Konya, Selçuklu, Turkey, 42000
- Selcuk University, Faculty of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age range 18-50
- applying to our clinic with the complaint of bruxism
- no psychological drug
- no active orthodontic treatment
- no musculoskeletal disease
- no removable prosthesis
- no obstructive sleep apnea syndrome
- "Class I" according to RDC/TMD classification
- "probable" according to bruxism classifiacation
- accept to fill out the questionnaire
- accept to give a blood sample
- being volunteer
- accept to sign the informed consent
Exclusion Criteria:
- indicate to quit the study at anytime
- not fully fill out the questionnaire
- encountering any complication during taking a blood sample
- can not take an adequate blood sample
presenting any below diseases;
- acute myocardial infarction
- pulmonary emboli
- deep venous thrombosis
- heart failure
- sepsis
- cerebral edema
- hypertensive encephalopathy
- hypoglycemia
- hepatic encephalopathy
- fluid-electrolyte disturbances
- acute-chronic renal failure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control Group
|
Blood samples will be taken from all volunteer participants in 1 yellow cap tube of 10 cc.
After the blood has cooled and the clot development process (approximately 15 minutes), the serum will be separated by centrifugation at 2000 g for 5 minutes.
Separated sera will be aliquoted and stored at -40°C until analysis.
The tryptophan and tryptophane metabolite levels of the participants will be measured by Liquid Chromatography-Tandem Mass Spectrometer API 3200 device.
The kynurenine, kynurenic acid, 3-HK, 3-HAA, 3-HOA, and QA values obtained as a result of this test will be recorded.
Anxiety and stress levels will be evaluated by applying State-Trait Anxiety Inventory and Perceived Stress Scale Tests by all volunteer participants.
Scores from these tests will be recorded.
|
|
Experimental: Bruxism Group
|
Blood samples will be taken from all volunteer participants in 1 yellow cap tube of 10 cc.
After the blood has cooled and the clot development process (approximately 15 minutes), the serum will be separated by centrifugation at 2000 g for 5 minutes.
Separated sera will be aliquoted and stored at -40°C until analysis.
The tryptophan and tryptophane metabolite levels of the participants will be measured by Liquid Chromatography-Tandem Mass Spectrometer API 3200 device.
The kynurenine, kynurenic acid, 3-HK, 3-HAA, 3-HOA, and QA values obtained as a result of this test will be recorded.
Anxiety and stress levels will be evaluated by applying State-Trait Anxiety Inventory and Perceived Stress Scale Tests by all volunteer participants.
Scores from these tests will be recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
serum tryptophane level measurement
Time Frame: blood sample will be taken 5 minutes after the patient sits the dental unit
|
serum tryptophane level measurement
|
blood sample will be taken 5 minutes after the patient sits the dental unit
|
|
serum kynurenin level measurement
Time Frame: blood sample will be taken 5 minutes after the patient sits the dental unit
|
serum kynurenin level measurement
|
blood sample will be taken 5 minutes after the patient sits the dental unit
|
|
serum kynurenic acid level measurement
Time Frame: blood sample will be taken 5 minutes after the patient sits the dental unit
|
serum kynurenic acid level measurement
|
blood sample will be taken 5 minutes after the patient sits the dental unit
|
|
serum quinolinic acid level measurement
Time Frame: blood sample will be taken 5 minutes after the patient sits the dental unit
|
serum quinolinic acid level measurement
|
blood sample will be taken 5 minutes after the patient sits the dental unit
|
|
serum 3-hydroxykynurenin level measurement
Time Frame: blood sample will be taken 5 minutes after the patient sits the dental unit
|
serum 3-hydroxykynurenin(3-HK) level measurement
|
blood sample will be taken 5 minutes after the patient sits the dental unit
|
|
serum 3-hydroxyanthranilic level measurement
Time Frame: blood sample will be taken 5 minutes after the patient sits the dental unit
|
serum 3-hydroxyanthranilic(3-HAA) level measurement
|
blood sample will be taken 5 minutes after the patient sits the dental unit
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gökhan Gürses, Assistant Professor, Selcuk University, Faculty of Dentistry
- Principal Investigator: Ali Ünlü, Professor, Selcuk University, Faculty of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SelcukU002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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