Salivary CortisolNCT06917976
Evaluating the Effects of Psychological Stress on Salivary Biomarkers in Pediatric Patients Visiting Pediatric and General Dental Clinic
An observational study of Salivary Cortisol and Salivary Alpha Amylase, run by Al-Mustansiriyah University.
Trial 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 . Read more about this study
- Who is it for?
- Ages 4 to 6 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Salivary Cortisol, Salivary Alpha Amylase
- What is being tested?
- to compare the effect of environment and attitude of dentist in children visiting specialized pediatric dental clinic and general dental clinic .
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 15 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- Men only
- Healthy volunteers accepted
- Child
Study population: male children from 4-6 years old with first dental clinic
Who may be able to join
- male
- 4-6 years old
- first dental visit
- patients with no systemic disease
Who cannot join
- medically compressed patient
- patients with systemic disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Salivary Cortisol, Salivary Alpha Amylase
- Being tested
- to compare the effect of environment and attitude of dentist in children visiting specialized pediatric dental clinic and general dental clinic .
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
to compare the effect of environment and attitude of dentist in children visiting specialized pediatric dental clinic and general dental clinic .Behavioural
the investigators will measure salivary cortisol and salivary alpha amylase and using children fear dental survey schedule - dental subscale
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion15 May 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary CortisolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donya ali abd alkadim, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917976
- Sponsor's protocol ID
- AL- Mustansiriyah University
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Psychological Stress on Salivary Biomarkers in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06917976
- Acronym / sponsor ID
- AL- Mustansiriyah University
- Conditions
- Salivary Cortisol, Salivary Alpha Amylase
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 6 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- male children from 4-6 years old with first dental clinic
Key inclusion criteria (4 listed)
- male
- 4-6 years old
- first dental visit
- patients with no systemic disease
Key exclusion criteria (2 listed)
- medically compressed patient
- patients with systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| to compare the effect of environment and attitude of dentist in children visiting specialized pediatric dental clinic and general dental clinic .the investigators will measure salivary cortisol and salivary alpha amylase and using children fear dental survey schedule - dental subscale | Behavioural | – |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Salivary Cortisol and Salivary Alpha Amylase, run by Al-Mustansiriyah University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donya ali abdalkadim, B.D.S (+9647735181734, danyaali@uomustansiriyah.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.