BruxismBRUXSALNCT07702019
Evaluation of Salivary Biomarkers in Individuals With Bruxism
An observational study of Bruxism, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to evaluate salivary biomarkers and perceived stress in adults with bruxism compared with healthy individuals. The study aims to determine whether salivary cortisol, immunoglobulin A (IgA), free kappa light chain (FLC-κ), free lambda light chain (FLC-λ), total free light chains… Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2025to 15 Jun 2026
- Phase
- Observational
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population consisted of adults with clinically diagnosed bruxism and age- and sex-matched healthy control participants recruited from the Faculty of Dentistry. All participants underwent clinical examination, completed the Perceived Stress Scale (PSS-14), and provided unstimulated saliva samples for biomarker analysis.
Who may be able to join
- Adults aged 25 to 50 years.
- Systemically healthy individuals.
- Presence of no more than four-unit fixed partial dentures.
- Absence of clinical signs of oral inflammation.
- Good oral hygiene.
- Individuals diagnosed with bruxism according to the study diagnostic criteria (bruxism group) or healthy volunteers without signs or symptoms of bruxism (control group).
- Ability and willingness to provide written informed consent.
Who cannot join
- Use of medications that may affect the nervous system or salivary gland function (e.g., benzodiazepines, antidepressants).
- Psychiatric disorders.
- Epilepsy.
- Diabetes mellitus or other pancreatic diseases.
- Current corticosteroid therapy.
- Cushing syndrome or Addison disease.
Show all 16Show fewer
- Pregnancy.
- Current smoking.
- Alcohol or substance abuse.
- History of facial trauma.
- Rheumatic muscle or joint disorders.
- Degenerative joint disease.
- Migraine.
- Use of medications affecting sleep or motor activity.
- Recent history of occlusal splint therapy.
- Salivary gland disorders, including Sjögren syndrome or autoimmune sialadenitis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun University Faculty of Dentistry
Giresun, 28200
About this study
Official title: Salivary Biomarkers and Perceived Stress in Individuals With Bruxism: A Case-Control Study
The goal of this observational study is to evaluate salivary biomarkers and perceived stress in adults with bruxism compared with healthy individuals. The study aims to determine whether salivary cortisol, immunoglobulin A (IgA), free kappa light chain (FLC-κ), free lambda light chain (FLC-λ), total free light chains, and perceived stress levels differ between individuals with bruxism and healthy controls. The main questions it aims to answer are:
- Do salivary cortisol, IgA, FLC-κ, FLC-λ, and total free light chain levels differ between individuals with bruxism and healthy controls?
- Is perceived stress associated with changes in salivary biomarkers in individuals with bruxism? Researchers will compare participants with bruxism and healthy control participants to evaluate differences in salivary biomarker levels and perceived stress.
Read more
Participants will:
- undergo a clinical examination for the diagnosis of bruxism or confirmation of healthy status;
- complete the Perceived Stress Scale (PSS-14) questionnaire;
- provide an unstimulated saliva sample for laboratory analysis of cortisol, IgA, free kappa light chain, free lambda light chain, and total free light chains.
Read the detailed description
Bruxism is a repetitive jaw-muscle activity characterized by clenching or grinding of the teeth and/or bracing or thrusting of the mandible during sleep or wakefulness. Increasing evidence suggests that psychological stress and neuroendocrine mechanisms may contribute to the development and progression of bruxism. Salivary biomarkers provide a non-invasive approach for evaluating physiological responses related to stress, immune function, and inflammation.
The purpose of this observational case-control study is to investigate whether salivary cortisol, immunoglobulin A (IgA), free kappa light chain (FLC-κ), free lambda light chain (FLC-λ), total free light chains, and perceived stress differ between individuals with bruxism and healthy controls. The study also aims to evaluate the relationship between perceived stress and salivary biomarker levels in individuals with bruxism.
Participants diagnosed with bruxism healthy control participants will undergo a standardized clinical examination. Perceived stress will be assessed using the Perceived Stress Scale (PSS-14). Unstimulated whole saliva samples will be collected under standardized conditions and analyzed for cortisol, IgA, free kappa light chain, free lambda light chain, and total free light chain concentrations using validated laboratory methods.
The results of this study are anticipated to enhance the understanding of the biological mechanisms involved in bruxism and to determine if salivary biomarkers can be used as objective markers of stress-related changes in bruxism patients.
- Conditions
- Bruxism
- Keywords
- salivary biomarkers, bruxism, cortisol, immunoglobulin A, free light chain, perceived stress
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bruxism | Adults diagnosed with bruxism based on clinical diagnostic criteria. | |
| Healthy Controls | Age- and sex-matched healthy adults without signs or symptoms of bruxism. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived stress score (PSS-14 score)
Comparison of PSS-14 scores between individuals with bruxism and non-bruxism controls.
Measured: Baseline
Secondary outcomes (1)
Salivary biomarker levels (cortisol, IgA, FLC-κ, FLC-λ, and total FLC)
Comparison of salivary cortisol, IgA, FLC-κ, FLC-λ, and total FLC concentrations between individuals with bruxism and non-bruxism controls
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start4 May 2025
- Primary completion30 Apr 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Collaborators
- Cumhuriyet University
- Responsible party
- Principal investigator, Tugce Cevik, Giresun University
- Investigators
- Tugce Cevik Sonmez, DDS, Principal investigator, Giresun University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702019
- Sponsor's protocol ID
- DIS-2025-344
- Acronym
- BRUXSAL
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Biomarkers and Perceived Stress in Individuals With Bruxism: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07702019
- Acronym / sponsor ID
- BRUXSAL / DIS-2025-344
- Conditions
- Bruxism
- Keywords
- salivary biomarkers, bruxism, cortisol, immunoglobulin A, free light chain, perceived stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Collaborators
- Cumhuriyet University
- Study start
- 4 May 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 14 Jul 2026 (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.
The goal of this observational study is to evaluate salivary biomarkers and perceived stress in adults with bruxism compared with healthy individuals. The study aims to determine whether salivary cortisol, immunoglobulin A (IgA), free kappa light chain (FLC-κ), free lambda light chain (FLC-λ), total free light chains, and perceived stress levels differ between individuals with bruxism and healthy controls. The main questions it aims to answer are:
- Do salivary cortisol, IgA, FLC-κ, FLC-λ, and total free light chain levels differ between individuals with bruxism and healthy controls?
- Is perceived stress associated with changes in salivary biomarkers in individuals with bruxism? Researchers will compare participants with bruxism and healthy control participants to evaluate differences in salivary biomarker levels and perceived stress.
Participants will:
- undergo a clinical examination for the diagnosis of bruxism or confirmation of healthy status;
- complete the Perceived Stress Scale (PSS-14) questionnaire;
- provide an unstimulated saliva sample for laboratory analysis of cortisol, IgA, free kappa light chain, free lambda light chain, and total free light chains.
Detailed description
Bruxism is a repetitive jaw-muscle activity characterized by clenching or grinding of the teeth and/or bracing or thrusting of the mandible during sleep or wakefulness. Increasing evidence suggests that psychological stress and neuroendocrine mechanisms may contribute to the development and progression of bruxism. Salivary biomarkers provide a non-invasive approach for evaluating physiological responses related to stress, immune function, and inflammation.
The purpose of this observational case-control study is to investigate whether salivary cortisol, immunoglobulin A (IgA), free kappa light chain (FLC-κ), free lambda light chain (FLC-λ), total free light chains, and perceived stress differ between individuals with bruxism and healthy controls. The study also aims to evaluate the relationship between perceived stress and salivary biomarker levels in individuals with bruxism.
Participants diagnosed with bruxism healthy control participants will undergo a standardized clinical examination. Perceived stress will be assessed using the Perceived Stress Scale (PSS-14). Unstimulated whole saliva samples will be collected under standardized conditions and analyzed for cortisol, IgA, free kappa light chain, free lambda light chain, and total free light chain concentrations using validated laboratory methods.
The results of this study are anticipated to enhance the understanding of the biological mechanisms involved in bruxism and to determine if salivary biomarkers can be used as objective markers of stress-related changes in bruxism patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bruxism | – | –Adults diagnosed with bruxism based on clinical diagnostic criteria. |
| Healthy Controls | – | –Age- and sex-matched healthy adults without signs or symptoms of bruxism. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consisted of adults with clinically diagnosed bruxism and age- and sex-matched healthy control participants recruited from the Faculty of Dentistry. All participants underwent clinical examination, completed the Perceived Stress Scale (PSS-14), and provided unstimulated saliva samples for biomarker analysis.
Key inclusion criteria (7 listed)
- Adults aged 25 to 50 years.
- Systemically healthy individuals.
- Presence of no more than four-unit fixed partial dentures.
- Absence of clinical signs of oral inflammation.
- Good oral hygiene.
Key exclusion criteria (16 listed)
- Use of medications that may affect the nervous system or salivary gland function (e.g., benzodiazepines, antidepressants).
- Psychiatric disorders.
- Epilepsy.
- Diabetes mellitus or other pancreatic diseases.
- Current corticosteroid therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perceived stress score (PSS-14 score)
Time frame: Baseline
Comparison of PSS-14 scores between individuals with bruxism and non-bruxism controls.
1 secondary outcome
Salivary biomarker levels (cortisol, IgA, FLC-κ, FLC-λ, and total FLC)
Time frame: Baseline
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 14 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Tugce Cevik Sonmez, DDS principal investigator
Giresun University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bruxism, run by Giresun 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 7 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 14 Jul 2026. 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?
Perceived stress score (PSS-14 score) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2026.