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Completed

NCT Number: NCT06730425

Examining Stress Salivary Biomarkers in Pediatric Patients Undergoing Dental Procedures

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).

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Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Midwestern University

Downers Grove, Illinois, 60515, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. Correlation between psychological distress and levels of salivary biomarkers

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Midwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2024
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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