NCT06917976

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

April 9, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

March 26, 2025

Last Update Submit

April 5, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • salivary alpha amylase

    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

    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.

Interventions

the investigators will measure salivary cortisol and salivary alpha amylase and using children fear dental survey schedule - dental subscale

Eligibility Criteria

Age4 Years - 6 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • medically compressed patient
  • patients with systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Donya ali abdalkadim, B.D.S

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
master student

Study Record Dates

First Submitted

March 26, 2025

First Posted

April 9, 2025

Study Start

April 15, 2025

Primary Completion

May 15, 2025

Study Completion

June 15, 2025

Last Updated

April 9, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share