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临床试验/NCT06730425
NCT06730425已完成不适用

Examining Stress Salivary Biomarkers in Pediatric Patients Undergoing Dental Procedures. A Prospective Longitudinal Study

Midwestern University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年9月9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
66
试验地点
1
主要终点
Correlation between psychological distress and levels of salivary biomarkers

研究概览

简要总结

Pediatric patients are susceptible to show signs of fear. One of the scenarios that have always been a source of fear is undergoing a dental procedure. Fear of undergoing dental procedure has been addressed as "dental fear", which can lead to avoidance of receiving dental care and may result to a decline in proper oral hygiene.

Fear stimulates multiple cerebral responses and can be often related to an increased stress level. Stress level fluctuations during dental procedures can be examined by blood and salivary biomarkers. Given accessibility and minimal invasiveness, the collection of saliva samples constitutes an easy and cost-effective diagnostic method to investigate a variety of oral and systemic conditions. Cortisol and alpha amylase are present within the saliva and their levels are supposedly influenced by stress. In contrast, salivary IgA is not known to be influenced by stress level and can be used in comparison as a non-stress salivary biomarker.

Fear of dental appointments is a well-known cause of stress and activation of the sympathetic nervous system in adolescents undergoing dental procedure. However, the examination of stress and stress-related factors in young individuals attending their first dental appointment compared to young individuals who present for an orthodontic application is largely understudies.

Therefore, the aims of the study are: 1) to measure stress salivary biomarkers in pediatric patients before undergoing dental and/or orthodontic procedures; 2) assess whether subjective stress to dental treatment (as measured by dental anxiety, stress, and dental fear) is associated with objective stress measurements (as measured by collection of stress salivary biomarkers).

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
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between the ages of 7 and 17
  • Ability to read and speak English language
  • Patients seen for a first visit at the pediatric or orthodontic departments of the dental institute of the Multispecialty Clinic at Midwestern University with a scheduled future appointment to start treatment in the pediatric or orthodontic department

排除标准

  • Older than 17 years of age or younger than 7 years of age
  • Unable to read and speak English language
  • Have any major health conditions or history of mental illness
  • Being a returning patient in the pediatric or orthodontic department of the dental institute of the Multispecialty Clinic at Midwestern University
  • Taking any systemic medications that would cause a change in salivary flow (e.g., oxybutynin, protein pump inhibitors)

结局指标

主要结局

Correlation between psychological distress and levels of salivary biomarkers

时间窗: At one time-point, before starting the dental procedure

Levels of dental fear (measured with 15-75 Children\'s Fear Survey Schedule-Dental Subscale, with values \>38 identifying dental fear), dental anxiety (measured with 8-40 Modified Child Dental Anxiety Scale, with values \>19 identifying anxiety) and self-perceived stress (measured with 1-40 Perceived Stress Scale, with values \>14 identifying stress) will be correlated with levels of salivary cortisol, alpha-amylase and IgA

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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