Evaluation of Salivary Biomarkers in Individuals With Bruxism (NCT07702019) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Salivary Biomarkers in Individuals With Bruxism
Turkey (Türkiye)56 participantsStarted 2025-05-04
Plain-language 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.
Who can participate
Age range
25 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 informed consent.
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 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.
* Salivary gland disorders, including Sjögren syndrome or autoimmune sialadenitis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.