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Salivary Stress Markers Associated With Malocclusion Severity

Determination of the Relationship Between Orthodontic Malocclusion Severity and Salivary Cortisol, Dehydroepiandrosterone and Chromogranin A Levels

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07116317
Enrollment
120
Registered
2025-08-11
Start date
2025-08-11
Completion date
2026-02-09
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion

Keywords

malocclusion, stress, cortisol, Dehydroepiandrosterone, Chromogranin A

Brief 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. 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.

Interventions

None listed

Sponsors

Recep Tayyip Erdogan University Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Rosenberg Self-Esteem Scale ScoreFirst dayA 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 ScoreFirst daySocial 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 SamplesSecond dayPrior 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.

Secondary

MeasureTime frameDescription
Concentration of Cortisol, Dehydroepiandrosterone (DHEA) and Chromogranin Aapproximately in the 4th monthSalivary 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactTuba KOSE, Assistant Professor
tuba.kose@erdogan.edu.tr+90 0506 956 72 08
Backup ContactOguz KOSE, Professor Dr.
oguz.kose@erdogan.edu.tr+90 0541 348 64 65

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026