Evaluation of Salivary Biomarkers in Individuals With Bruxism

NCT07702019 | Completed

• 1 other identifier: DIS-2025-344
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bruxism

Keywords

salivary biomarkers; bruxism; cortisol; immunoglobulin A; free light chain; perceived stress

Outcome Measures

Primary Outcomes (1)

• Perceived stress score (PSS-14 score)

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

  Baseline

Secondary Outcomes (1)

• Salivary biomarker levels (cortisol, IgA, FLC-κ, FLC-λ, and total FLC)

  Baseline

Study Arms (2)

Bruxism

Adults diagnosed with bruxism based on clinical diagnostic criteria.

Healthy Controls

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

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Giresun University: lead
• Cumhuriyet University: collaborator

Study Sites (1)

Giresun University Faculty of Dentistry

Giresun, 28200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Study Officials

• Tugce Cevik Sonmez, DDS

  Giresun University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 14, 2026
• Study Start: May 4, 2025
• Primary Completion: April 30, 2026
• Study Completion: June 15, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)