Clinical trial NCT06730425: Examining Stress Salivary Biomarkers in Pediatric Patients Undergoing Dental Procedures
Official title: Examining Stress Salivary Biomarkers in Pediatric Patients Undergoing Dental Procedures. A Prospective Longitudinal Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dental Anxiety
Dental Fear
Stress
Pediatric Population
Keywords: dental anxiety
pediatric patients
salivary biomarkers
salivary diagnostics
dental fear
stress
salivary cortisol
salivary alpha-amylase
salivary IgA
Lead sponsor: Midwestern University
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 66
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New pediatric patients that needs treatment at either the pediatric or the orthodontic departments of the dental institute at Midwestern University

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).


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)

Primary outcomes:
measure: Correlation between psychological distress and levels of salivary biomarkers
timeFrame: At one time-point, before starting the dental procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Downers Grove
country: United States
facility: Midwestern University
state: Illinois
city: Downers Grove
country: United States
facility: Midwestern University
state: Illinois
Study officials:
References: