BruxismNCT05760482
Evaluation of the Relationship Between Bruxism and Tryptophan Metabolites
A study testing Metobolites serum level measurement and Anxiety and stress level measurement in people with Bruxism and Anxiety State, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Bruxism, Anxiety State, Tryptophan Metabolism Alterations
- What is being tested?
- Metobolites serum level measurement and Anxiety and stress level measurement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Sep 2023to 1 Jun 2024
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- pulmonary emboli
- deep venous thrombosis
- heart failure
- sepsis
- cerebral edema
- hypertensive encephalopathy
- hypoglycemia
- hepatic encephalopathy
- fluid-electrolyte disturbances
- acute-chronic renal failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University, Faculty of Dentistry
Konya, Selçuklu, 42000
About this study
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.
Read the 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."
- Conditions
- Bruxism, Anxiety State, Tryptophan Metabolism Alterations
- Being tested
- Metobolites serum level measurement, Anxiety and stress level measurement
- Medical subject headings
- Bruxism, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metobolites serum level measurementDiagnostic test
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 level measurementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Bruxism Group | Experimental | Not described Receives: Diagnostic Test: Metobolites serum level measurement; Behavioral: Anxiety and stress level measurement |
| Control Group | Experimental | Not described Receives: Diagnostic Test: Metobolites serum level measurement; Behavioral: Anxiety and stress level measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum tryptophane level measurement
serum tryptophane level measurement
Measured: blood sample will be taken 5 minutes after the patient sits the dental unit
serum kynurenin level measurement
serum kynurenin level measurement
Measured: blood sample will be taken 5 minutes after the patient sits the dental unit
serum kynurenic acid level measurement
serum kynurenic acid level measurement
Measured: blood sample will be taken 5 minutes after the patient sits the dental unit
serum quinolinic acid level measurement
serum quinolinic acid level measurement
Measured: 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
Measured: 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
Measured: blood sample will be taken 5 minutes after the patient sits the dental unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start4 Sep 2023
- Primary completion31 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BruxismStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokhan Gurses, Selcuk University
- Investigators
- Gökhan Gürses, Assistant Professor, Study chair, Selcuk University, Faculty of DentistryAli Ünlü, Professor, Principal investigator, Selcuk University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760482
- Sponsor's protocol ID
- SelcukU002
- Status last verified
- Jun 2024
- First submitted
- 26 Feb 2023
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gurses G, Unlu A. Evaluation of the Relationship Between Bruxism and Tryptophan Metabolites: A Case-Control Study. J Oral Rehabil. 2026 Jun;53(6):1187-1198. doi: 10.1111/joor.70174. Epub 2026 Mar 6.
PubMed 41789846
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Bruxism and Tryptophan Metabolites
- ClinicalTrials.gov ID
- NCT05760482
- Acronym / sponsor ID
- SelcukU002
- Conditions
- Bruxism, Anxiety State, Tryptophan Metabolism Alterations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 8 Mar 2023 (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.
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."
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bruxism Group | Experimental | Diagnostic Test: Metobolites serum level measurement, Behavioral: Anxiety and stress level measurement |
| Control Group | Experimental | Diagnostic Test: Metobolites serum level measurement, Behavioral: Anxiety and stress level measurement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- age range 18-50
- applying to our clinic with the complaint of bruxism
- no psychological drug
- no active orthodontic treatment
- no musculoskeletal disease
Key exclusion criteria (16 listed)
- 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;
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 |
|---|---|---|
| Metobolites serum level measurementBlood 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. | Diagnostic test | Bruxism Group, Control Group |
| Anxiety and stress level measurementAnxiety 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. | Behavioural | Bruxism Group, Control Group |
Primary outcome
serum tryptophane level measurement
Time frame: blood sample will be taken 5 minutes after the patient sits the dental unit
serum tryptophane level measurement
serum kynurenin level measurement
Time frame: blood sample will be taken 5 minutes after the patient sits the dental unit
serum kynurenin level measurement
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Derived from this study: PubMed 41789846Gurses G, Unlu A. Evaluation of the Relationship Between Bruxism and Tryptophan Metabolites: A Case-Control Study. J Oral Rehabil. 2026 Jun;53(6):1187-1198. doi: 10.1111/joor.70174. Epub 2026 Mar 6.
Related trials for Bruxism
RecruitingObservational study
Bruxism, Anxiety, and Periodontal Status Among Dental Students
Bruxism, Anxiety
RecruitingObservational study
Movement of Dental Implants During Osseointegration
Dental Implants, Osseointegration
Enrolling by invitationObservational study
The General Aim is to Implement Clinical Assessment of Overload by Voluntary Bite Force Registration to Enable Future Simple But Precise Risk Assessment to Provide Individualized Treatment Plans.
Dental Implant, Bruxism
RecruitingObservational study
Effect Of Orofacial Pain Therapy On Bruxism
Masticatory Myofascial Pain
Not yet recruiting
Influence Of Different Relaxation Techniques On Stress Level For Patients With Bruxism Using Salivary Biomarkers.
Bruxism, Stress (Psychology)
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.
Gökhan Gürses, Assistant Professor study chair
Selcuk University, Faculty of Dentistry
Ali Ünlü, Professor principal investigator
Selcuk University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metobolites serum level measurement and Anxiety and stress level measurement in people with Bruxism and Anxiety State, run by Selcuk University at 1 site in Turkey (Türkiye).
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 13 inclusion and 16 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: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum tryptophane level measurement (time frame: blood sample will be taken 5 minutes after the patient sits the dental unit). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05760482, which also lists 1 linked publication.
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 6 Jun 2024.