跳至主要内容
临床试验/NCT07702019
NCT07702019已完成不适用

Salivary Biomarkers and Perceived Stress in Individuals With Bruxism: A Case-Control Study

Giresun University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Perceived stress score (PSS-14 score)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Bruxism

Adults diagnosed with bruxism based on clinical diagnostic criteria.

Healthy Controls

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

结局指标

主要结局

Perceived stress score (PSS-14 score)

时间窗: Baseline

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

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tugce Cevik

Assistant Professor

Giresun University

研究点 (1)

Loading locations...

相似试验