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NCT Number: NCT07116317

Salivary Stress Markers Associated With Malocclusion Severity

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.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthodontics of the Faculty of Dentistry of Recep Tayyip Erdogan University

Rize, Rize Province, 53200, Turkey (Türkiye)

Location contact

RTEU Faculty of Dentistry, Department of Orthodontics

CONTACT

[email protected]

+90 464 222 00 00

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

Concentration of Cortisol, Dehydroepiandrosterone (DHEA) and Chromogranin A

Time frame: approximately in the 4th month

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Oguz KOSE, Professor Dr.

CONTACT

[email protected]

+90 0541 348 64 65

Tuba KOSE, Assistant Professor

CONTACT

[email protected]

+90 0506 956 72 08

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Aug 11, 2025
Registry last updated: Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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