Salivary Stress Markers Associated With Malocclusion Severity

NCT07116317 | Not Yet Recruiting DMC

• 1 other identifier: ortho04/2025
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion

Keywords

malocclusion; stress; cortisol; Dehydroepiandrosterone; Chromogranin A

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Second day

Secondary Outcomes (1)

• Concentration of Cortisol, Dehydroepiandrosterone (DHEA) and Chromogranin A

  approximately in the 4th month

Study Arms (4)

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

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients coming to Recep Tayyip Erdogan University Faculty of Dentistry Orthodontics Clinic for routine orthodontic treatment

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead

Study Sites (1)

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

Rize, Rize Province, 53200, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples will be stored until the day they are to be biochemically analyzed to prevent deterioration.

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Oguz KOSE, Professor Dr.

  Recep Tayyip Erdogan University Faculty of Dentistry

  STUDY DIRECTOR

Central Study Contacts

Tuba KOSE, Assistant Professor

CONTACT

+90 0506 956 72 08; tuba.kose@erdogan.edu.tr

Oguz KOSE, Professor Dr.

CONTACT

+90 0541 348 64 65; oguz.kose@erdogan.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 11, 2025
• Study Start: August 11, 2025
• Primary Completion: December 15, 2025
• Study Completion: February 9, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)