NCT05760482

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

September 4, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

February 26, 2023

Last Update Submit

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

EXPERIMENTAL
Diagnostic Test: Metobolites serum level measurementBehavioral: Anxiety and stress level measurement

Control Group

EXPERIMENTAL
Diagnostic Test: Metobolites serum level measurementBehavioral: Anxiety and stress level measurement

Interventions

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.

Bruxism GroupControl Group

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.

Bruxism GroupControl Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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)

Location

MeSH Terms

Conditions

BruxismAnxiety Disorders

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehaviorMental Disorders

Study Officials

  • Gökhan Gürses, Assistant Professor

    Selcuk University, Faculty of Dentistry

    STUDY CHAIR
  • Ali Ünlü, Professor

    Selcuk University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

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

Locations