Stress BiomarkersNCT06990919
Evaluation of the Stress Levels of Children and Their Parents
A study testing Saliva collection in people with Stress Biomarkers and Anxiety, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The stress levels of the participating child and their parents were evaluated using saliva to measure the stress biomarkers. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Stress Biomarkers, Anxiety
- What is being tested?
- Saliva collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2021to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- who did not allow their dental treatments to be completed using behavioral guidance techniques in the clinical environment.
- who had no physical or psychosocial diseases were recruited Exclusion Criteria: The children
- who were unable to give a saliva sample due to increased anxiety or inadequate saliva.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Of The Impact Of Dental Rehabilitation Under General Anesthesia On The Stress Levels Of Children And Their Parents
The stress levels of the participating child and their parents were evaluated using saliva to measure the stress biomarkers.
Read the detailed description
All of the dental treatments of the enrolled children were performed under general anesthesia. The stress biomarkers, such as alpha-amylase and cortisol levels, were measured from the participating child's saliva samples at pre-operative and post-operative. Additionally, the stress levels of the mothers were evaluated by questionnaires at the beginning of the study.
- Conditions
- Stress Biomarkers, Anxiety
- Being tested
- Saliva collection
- Keywords
- Alpha-amylase, Cortisol, Dental anxiety, general anesthesia, dental treatments
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva collectionOther
Pre-operative saliva collected before the full mouth treatment under general anesthesia while, post-operative saliva collected at 1-month follow-up after general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Enrolled children | Other | All of the enrolled children have been followed for 1-month. Pre-operative and post-operative saliva samples have been collected from all participating children. Receives: Other: Saliva collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
alpha-amylase
salivary biomarker
Measured: 1-month
cortisol
salivary biomarker
Measured: 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start6 Jan 2021
- Primary completion1 Dec 2023
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress BiomarkersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem Sakaryali Uyar, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990919
- Sponsor's protocol ID
- KA20/82
- Status last verified
- May 2025
- First submitted
- 18 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data presented in this study are available from the corresponding authors upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Impact Of Dental Rehabilitation Under General Anesthesia On The Stress Levels Of Children And Their Parents
- ClinicalTrials.gov ID
- NCT06990919
- Acronym / sponsor ID
- KA20/82
- Conditions
- Stress Biomarkers, Anxiety
- Keywords
- Alpha-amylase, Cortisol, Dental anxiety, general anesthesia, dental treatments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 25 May 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 stress levels of the participating child and their parents were evaluated using saliva to measure the stress biomarkers.
Detailed description
All of the dental treatments of the enrolled children were performed under general anesthesia. The stress biomarkers, such as alpha-amylase and cortisol levels, were measured from the participating child's saliva samples at pre-operative and post-operative. Additionally, the stress levels of the mothers were evaluated by questionnaires at the beginning of the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled children | Other | Other: Saliva collectionAll of the enrolled children have been followed for 1-month. Pre-operative and post-operative saliva samples have been collected from all participating children. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- who did not allow their dental treatments to be completed using behavioral guidance techniques in the clinical environment.
- who had no physical or psychosocial diseases were recruited Exclusion Criteria: The children
- who were unable to give a saliva sample due to increased anxiety or inadequate saliva.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Saliva collectionPre-operative saliva collected before the full mouth treatment under general anesthesia while, post-operative saliva collected at 1-month follow-up after general anesthesia. | Other | Enrolled children |
Primary outcome
alpha-amylase
Time frame: 1-month
salivary biomarker
cortisol
Time frame: 1-month
salivary biomarker
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No. The data presented in this study are available from the corresponding authors upon reasonable request.
Related trials for Stress Biomarkers
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Active, not recruitingObservational study
The Developmental Origins of Suicide Mortality
Suicide Mortality
Not yet recruitingObservational study
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
Renal Transplantation; Complication, Renal Transplant
RecruitingObservational study
Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease
Gaucher Disease Type I, Oxidative Stress
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saliva collection in people with Stress Biomarkers and Anxiety, run by Baskent University at 1 site in Turkey (Türkiye).
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 3 inclusion and 0 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: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alpha-amylase (time frame: 1-month). 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 30 May 2025.