Evaluating the Effects of Psychological Stress on Salivary Biomarkers in Pediatric Patients Visiting Pediatric and General Dental Clinic

April 5, 2025 updated by: Donya ali abd alkadim, Al-Mustansiriyah University

Evaluating the Effects of Psychological Stress on Salivary Biomarkers in Pediatric Patients

the goal of this study is to test the effect of psychological stress on pediatric patients visiting specialized and general dental clinic by measure salivary cortisol and salivary alpha amylase and by use children fear survey schedule -dental subscale .

80 male subjects will be enrolled in this study between 4-6 years old with first dental visit ,40 subjects visiting specialized pediatric dental clinic to see the effect of specific environment and attitude of dentist on child stress ,and 40 subjects visiting general dental clinic with normal environment and general dentist .

the method of study is by taking two saliva sample from child , first when he will enter the clinic at reception and second after half hour when he will diagnosed without any type of treatment.

Study Overview

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

male children from 4-6 years old with first dental clinic

Description

Inclusion Criteria:

  • male
  • 4-6 years old
  • first dental visit
  • patients with no systemic disease

Exclusion Criteria:

  • medically compressed patient
  • patients with systemic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
salivary alpha amylase
Time Frame: Baseline: saliva collection for cortisol and salivary alpha amylase measurement. up to half hour :saliva collection will be performed again as described at base line visit.
measure salivary alpha amylase before and after half hour to see if the environment and attitude of dentist effect on salivary alpha amylase hormone.
Baseline: saliva collection for cortisol and salivary alpha amylase measurement. up to half hour :saliva collection will be performed again as described at base line visit.
salivary cortisol
Time Frame: Baseline: saliva collection for cortisol and salivary alpha amylase measurement. up to half hour :saliva collection will be performed again as described at base line visit.
measure salivary cortisol before and after half hour to see if the environment and attitude of dentist effect on cortisol hormone.
Baseline: saliva collection for cortisol and salivary alpha amylase measurement. up to half hour :saliva collection will be performed again as described at base line visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2025

Primary Completion (Estimated)

May 15, 2025

Study Completion (Estimated)

June 15, 2025

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

April 5, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL- Mustansiriyah University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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