Evaluation of the Relationship Between Bruxism and Tryptophan Metabolites
1 other identifier
interventional
92
1 country
1
Brief Summary
Psychological causes are often cited as the most important of the underlying factors for bruxism. However, there are very few studies that can objectively demonstrate this. There are studies that are generally based on subjective data, that is, on questionnaires that indicate anxiety or stress. Recent studies have shown that tryptophan and its metabolites are associated with psychological health. In this study, researchers will measure the serum values of metabolites in the tryptophan pathway. Also, researchers will observe whether these metabolite levels differ significantly in patients with and without bruxism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2023
CompletedFirst Posted
Study publicly available on registry
March 8, 2023
CompletedStudy Start
First participant enrolled
September 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedJune 6, 2024
June 1, 2024
9 months
February 26, 2023
June 5, 2024
Conditions
Outcome Measures
Primary Outcomes (6)
serum tryptophane level measurement
serum tryptophane level measurement
blood sample will be taken 5 minutes after the patient sits the dental unit
serum kynurenin level measurement
serum kynurenin level measurement
blood sample will be taken 5 minutes after the patient sits the dental unit
serum kynurenic acid level measurement
serum kynurenic acid level measurement
blood sample will be taken 5 minutes after the patient sits the dental unit
serum quinolinic acid level measurement
serum quinolinic acid level measurement
blood sample will be taken 5 minutes after the patient sits the dental unit
serum 3-hydroxykynurenin level measurement
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
serum 3-hydroxyanthranilic(3-HAA) level measurement
blood sample will be taken 5 minutes after the patient sits the dental unit
Study Arms (2)
Bruxism Group
EXPERIMENTALControl Group
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Selcuk University, Faculty of Dentistry
Konya, Selçuklu, 42000, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gökhan Gürses, Assistant Professor
Selcuk University, Faculty of Dentistry
- PRINCIPAL INVESTIGATOR
Ali Ünlü, Professor
Selcuk University, Faculty of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 26, 2023
First Posted
March 8, 2023
Study Start
September 4, 2023
Primary Completion
May 31, 2024
Study Completion
June 1, 2024
Last Updated
June 6, 2024
Record last verified: 2024-06