ClinicalTrials.gg
CompletedNCT07702019BRUXSALUpdated Jul 14, 2026

Evaluation of Salivary Biomarkers in Individuals With Bruxism

An observational study in Bruxism, sponsored by Giresun University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Giresun University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
56
Ages
25 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 66 studies in Bruxism with a site in Turkey — 11 open to participants now, 13 under way, none of them phase 3. Bruxism · Turkey.

Enrollment
19th of 25
56 · median 76
Started
2025
with 17 others
Observational
25 of 66
4 open now
Registered
61st of 66
by date

Among the 66 studies in Bruxism with a site in Turkey, this one is the 19th largest by enrollment of the 25 observational ones, is one of 18 that started in 2025, is one of 25 observational ones, and was the 61st registered.

By phase

66 studies; the count open now beside each. This study's row is marked.

No phase39 · 5 open
Observationalthis study25 · 4 open
Phase 11 · 1 open
Phase 41 · 1 open

By the year they started

First in 2017; this study’s year is marked. 18 started in 2025.

Size and results

Median enrollment 36 across the 41 interventional studies, 76 across the 25 observational. Of the 52 that completed or were terminated, 2 (4%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 66 studies in Bruxism with a site in Turkey, or all of them as a file.
02

Study 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, 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.
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.

03

Conditions studied

  • Bruxism

Browse trials for

Keywords

  • salivary biomarkers
  • bruxism
  • cortisol
  • immunoglobulin A
  • free light chain
  • perceived stress
04

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • 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 therapy.
  • Cushing syndrome or Addison disease.
  • 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 sialadenitis.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
56 participants (actual)
Patient registry
No

Groups and cohorts

  • Bruxism

    Adults diagnosed with bruxism based on clinical diagnostic criteria.

  • Healthy Controls

    Age- and sex-matched healthy adults without signs or symptoms of bruxism.

06

What researchers measure

Primary outcomes

  1. Perceived stress score (PSS-14 score)

    Comparison of PSS-14 scores between individuals with bruxism and non-bruxism controls.

    Time frame: 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

    Time frame: Baseline

07

Study locations

1 site
  • Giresun University Faculty of Dentistry
    Giresun, 28200, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2025 to primary completion in Apr 2026, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2026
First posted
Jul 14, 2026
StartActual
May 4, 2025
Primary completionActual
Apr 30, 2026
CompletionActual
Jun 15, 2026
Last update
Jul 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07702019
Lead sponsor
Giresun University
Responsible party
Tugce Cevik (Assistant Professor, Giresun University) — Principal investigator
First posted
Jul 14, 2026
Start date
May 4, 2025
Primary completion
Apr 30, 2026
Completion
Jun 15, 2026
Last update
Jul 14, 2026

Study contacts

Tugce Cevik Sonmez, DDS
principal investigator · Giresun University Faculty of Dentistry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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