MalocclusionNCT07116317
Salivary Stress Markers Associated With Malocclusion Severity
An observational study of Malocclusion, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study is to evaluate the relationship between the severity of orthodontic malocclusion and psychophysiological stress levels in individuals aged 12 to 18 years. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Malocclusion
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Aug 2025to 9 Feb 2026
- How long will I take part?
- 1 Day
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients coming to Recep Tayyip Erdogan University Faculty of Dentistry Orthodontics Clinic for routine orthodontic treatment
Who may be able to join
- Patients between the ages of 12 and 18,
- Patients with all permanent teeth,
- Patients with the ability to read and understand,
- Patients with a cephalometric evaluation file and maxillary and mandibular impression dental models before diagnostic orthodontic treatment.
Who cannot join
- Presence of any congenital craniofacial deformity (cleft lip and palate or any other craniofacial syndrome or deformity),
- Patients who have previously initiated or completed orthodontic treatment,
- Patients with a history of psychiatric illness, the presence of caries, facial asymmetry, and any skin deformity affecting facial aesthetics.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Department of Orthodontics of the Faculty of Dentistry of Recep Tayyip Erdogan University
Rize, Rize Province, 53200
RTEU Faculty of Dentistry, Department of Orthodontics, +90 464 222 00 00, dis@erdogan.edu.tr
About this study
Official title: Determination of the Relationship Between Orthodontic Malocclusion Severity and Salivary Cortisol, Dehydroepiandrosterone and Chromogranin A Levels
The aim of this observational study is to evaluate the relationship between the severity of orthodontic malocclusion and psychophysiological stress levels in individuals aged 12 to 18 years. The study will investigate the association between malocclusion severity and both stress-related salivary biomarkers and psychosocial factors.
The primary research question is as follows:
Read more
As the severity of orthodontic malocclusion increases, do levels of salivary stress biomarkers (cortisol, DHEA, and chromogranin A), self-esteem, and social appearance anxiety significantly change in adolescent individuals?
Method:
The study will include participants between the ages of 12 and 18. The severity of malocclusion will be assessed through clinical examination. Psychological assessments will be conducted using structured questionnaires to measure self-esteem and social appearance anxiety. In addition, saliva samples collected in the morning will be analyzed using the ELISA method to determine levels of cortisol, DHEA, and chromogranin A (CgA). The data will be statistically analyzed to identify the potential relationship between orthodontic malocclusion and biological and psychosocial indicators of stress.
- Conditions
- Malocclusion
- Keywords
- malocclusion, stress, cortisol, Dehydroepiandrosterone, Chromogranin A
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with normal or minor malocclusion | Patients with a Dental Aesthetic Index score of ≤25 | |
| Patients with moderate malocclusion | Patients with a Dental Aesthetic Index score of 26-30 | |
| Patients with severe malocclusion | Patients with a Dental Aesthetic Index score of 31-35 | |
| Patients with obstructive malocclusion | Patients with a Dental Aesthetic Index score of ≥36 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rosenberg Self-Esteem Scale Score
A four-point scale will be used to score responses to the 10 items. Positive questions are scored as 3: Strongly agree; 2: Agree; 1: Disagree; and 0: Strongly disagree, while negative questions are scored as 0: Strongly agree; 1: Agree; 2: Disagree; and 3: Strongly disagree. According to the final total score of the Rosenberg Self-Esteem Scale scores between 0-15, 15-25, and 25-30 indicate low, normal, and high self-esteem levels, respectively.
Measured: First day
Social Appearance Anxiety Scale Score
Social Appearance Anxiety Scale 16-item scale concerns how patients feel about their appearance. A score of 1 to 5 is given for each item as follows: 1, completely disagree; 2, partially disagree; 3, unsure; 4, partially agree; 5, I completely agree. Scores range from 16 to 80, with higher scores representing greater social appearance anxiety.
Measured: First day
Collection of Saliva Samples
Prior to saliva collection, participants will be instructed to abstain from caffeine and/or nicotine for at least 4 hours and alcohol for at least 24 hours. Saliva will be collected between 9:00 AM and 11:00 AM to minimize circadian variations. Unstimulated saliva flow rate will be collected over 10 minutes using the spitting method and will be expressed in mL/min.
Measured: Second day
Secondary outcomes (1)
Concentration of Cortisol, Dehydroepiandrosterone (DHEA) and Chromogranin A
Salivary cortisol, DHEA and Chromogranin A will be obtained from unstimulated whole saliva samples. Saliva samples will be stored at -20°C until analyzed. Human salivary cortisol, DHEA, and Chromogranin A will be measured using radioenzyme immunoassay using a commercial enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer's instructions.
Measured: approximately in the 4th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start11 Aug 2025 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion9 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek KARADOĞAN, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Oguz KOSE, Professor Dr., Study director, Recep Tayyip Erdogan University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116317
- Sponsor's protocol ID
- ortho04/2025
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Relationship Between Orthodontic Malocclusion Severity and Salivary Cortisol, Dehydroepiandrosterone and Chromogranin A Levels
- ClinicalTrials.gov ID
- NCT07116317
- Acronym / sponsor ID
- ortho04/2025
- Conditions
- Malocclusion
- Keywords
- malocclusion, stress, cortisol, Dehydroepiandrosterone, Chromogranin A
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 11 Aug 2025 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 9 Feb 2026 (estimated)
- First posted
- 11 Aug 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 aim of this observational study is to evaluate the relationship between the severity of orthodontic malocclusion and psychophysiological stress levels in individuals aged 12 to 18 years. The study will investigate the association between malocclusion severity and both stress-related salivary biomarkers and psychosocial factors.
The primary research question is as follows:
As the severity of orthodontic malocclusion increases, do levels of salivary stress biomarkers (cortisol, DHEA, and chromogranin A), self-esteem, and social appearance anxiety significantly change in adolescent individuals?
Method:
The study will include participants between the ages of 12 and 18. The severity of malocclusion will be assessed through clinical examination. Psychological assessments will be conducted using structured questionnaires to measure self-esteem and social appearance anxiety. In addition, saliva samples collected in the morning will be analyzed using the ELISA method to determine levels of cortisol, DHEA, and chromogranin A (CgA). The data will be statistically analyzed to identify the potential relationship between orthodontic malocclusion and biological and psychosocial indicators of stress.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with normal or minor malocclusion | – | –Patients with a Dental Aesthetic Index score of ≤25 |
| Patients with moderate malocclusion | – | –Patients with a Dental Aesthetic Index score of 26-30 |
| Patients with severe malocclusion | – | –Patients with a Dental Aesthetic Index score of 31-35 |
| Patients with obstructive malocclusion | – | –Patients with a Dental Aesthetic Index score of ≥36 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients coming to Recep Tayyip Erdogan University Faculty of Dentistry Orthodontics Clinic for routine orthodontic treatment
Key inclusion criteria (4 listed)
- Patients between the ages of 12 and 18,
- Patients with all permanent teeth,
- Patients with the ability to read and understand,
- Patients with a cephalometric evaluation file and maxillary and mandibular impression dental models before diagnostic orthodontic treatment.
Key exclusion criteria (3 listed)
- Presence of any congenital craniofacial deformity (cleft lip and palate or any other craniofacial syndrome or deformity),
- Patients who have previously initiated or completed orthodontic treatment,
- Patients with a history of psychiatric illness, the presence of caries, facial asymmetry, and any skin deformity affecting facial aesthetics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rosenberg Self-Esteem Scale Score
Time frame: First day
A four-point scale will be used to score responses to the 10 items. Positive questions are scored as 3: Strongly agree; 2: Agree; 1: Disagree; and 0: Strongly disagree, while negative questions are scored as 0: Strongly agree; 1: Agree; 2: Disagree; and 3: Strongly disagree. According to the final total score of the Rosenberg Self-Esteem Scale scores between 0-15, 15-25, and 25-30 indicate low, normal, and high self-esteem levels, respectively.
Social Appearance Anxiety Scale Score
Time frame: First day
Social Appearance Anxiety Scale 16-item scale concerns how patients feel about their appearance. A score of 1 to 5 is given for each item as follows: 1, completely disagree; 2, partially disagree; 3, unsure; 4, partially agree; 5, I completely agree. Scores range from 16 to 80, with higher scores representing greater social appearance anxiety.
Collection of Saliva Samples
Time frame: Second day
Prior to saliva collection, participants will be instructed to abstain from caffeine and/or nicotine for at least 4 hours and alcohol for at least 24 hours. Saliva will be collected between 9:00 AM and 11:00 AM to minimize circadian variations. Unstimulated saliva flow rate will be collected over 10 minutes using the spitting method and will be expressed in mL/min.
1 secondary outcome
Concentration of Cortisol, Dehydroepiandrosterone (DHEA) and Chromogranin A
Time frame: approximately in the 4th month
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 11 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Oguz KOSE, Professor Dr. study director
Recep Tayyip Erdogan University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion, run by Recep Tayyip Erdogan University Training and Research Hospital 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 4 inclusion and 3 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 11 Aug 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?
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 Tuba KOSE, Assistant Professor (+90 0506 956 72 08, tuba.kose@erdogan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rosenberg Self-Esteem Scale Score (time frame: First day). The study lists 3 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 11 Aug 2025.