Examining Stress Salivary Biomarkers in Pediatric Patients Undergoing Dental Procedures

NCT ID: NCT06730425

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-09
• Study Completion Date: 2025-05-30

Brief Summary

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).

Conditions

Dental Anxiety; Dental Fear; Stress; Pediatric Population

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Pediatric patients seen at the pediatric or orthodontic department

New pediatric patients seen for the first time at either the pediatric or the orthodontic department at the dental clinic of Midwestern University to start either a dental procedure or an orthodontic treatment

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Midwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Midwestern University

Downers Grove, Illinois, United States

Countries

United States

Other Identifiers

CIRB#IL24015

Identifier Type: -

Identifier Source: org_study_id