search
Back to results

Evaluation of the Relationship Between Bruxism and Tryptophan Metabolites

Primary Purpose

Bruxism, Anxiety State, Tryptophan Metabolism Alterations

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Metobolites serum level measurement
Anxiety and stress level measurement
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bruxism

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Selcuk University, Faculty of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bruxism Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

serum tryptophane level measurement
serum tryptophane level measurement
serum kynurenin level measurement
serum kynurenin level measurement
serum kynurenic acid level measurement
serum kynurenic acid level measurement
serum quinolinic acid level measurement
serum quinolinic acid level measurement
serum 3-hydroxykynurenin level measurement
serum 3-hydroxykynurenin(3-HK) level measurement
serum 3-hydroxyanthranilic level measurement
serum 3-hydroxyanthranilic(3-HAA) level measurement

Secondary Outcome Measures

Full Information

First Posted
February 26, 2023
Last Updated
September 4, 2023
Sponsor
Selcuk University
search

1. Study Identification

Unique Protocol Identification Number
NCT05760482
Brief Title
Evaluation of the Relationship Between Bruxism and Tryptophan Metabolites
Official Title
Evaluation of the Relationship Between Bruxism and Tryptophan Metabolites
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bruxism, Anxiety State, Tryptophan Metabolism Alterations

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bruxism Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Metobolites serum level measurement
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Anxiety and stress level measurement
Intervention Description
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.
Primary Outcome Measure Information:
Title
serum tryptophane level measurement
Description
serum tryptophane level measurement
Time Frame
blood sample will be taken 5 minutes after the patient sits the dental unit
Title
serum kynurenin level measurement
Description
serum kynurenin level measurement
Time Frame
blood sample will be taken 5 minutes after the patient sits the dental unit
Title
serum kynurenic acid level measurement
Description
serum kynurenic acid level measurement
Time Frame
blood sample will be taken 5 minutes after the patient sits the dental unit
Title
serum quinolinic acid level measurement
Description
serum quinolinic acid level measurement
Time Frame
blood sample will be taken 5 minutes after the patient sits the dental unit
Title
serum 3-hydroxykynurenin level measurement
Description
serum 3-hydroxykynurenin(3-HK) level measurement
Time Frame
blood sample will be taken 5 minutes after the patient sits the dental unit
Title
serum 3-hydroxyanthranilic level measurement
Description
serum 3-hydroxyanthranilic(3-HAA) level measurement
Time Frame
blood sample will be taken 5 minutes after the patient sits the dental unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gökhan Gürses, Assistant Professor
Phone
+905052595359
Email
gokhangurses.akademik@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gökhan Gürses, Assistant Professor
Organizational Affiliation
Selcuk University, Faculty of Dentistry
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ali Ünlü, Professor
Organizational Affiliation
Selcuk University, Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Selcuk University, Faculty of Dentistry
City
Konya
State/Province
Selçuklu
ZIP/Postal Code
42000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gökhan Gürses, Assistant Professor
Phone
+905052595359
Email
gokhangurses.akademik@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Relationship Between Bruxism and Tryptophan Metabolites

We'll reach out to this number within 24 hrs