Salivary Stress Markers Associated With Malocclusion Severity

ConditionMalocclusion
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-18
SponsorRecep Tayyip Erdogan University Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

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

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 4 trial groups
Group A: Patients with normal or minor malocclusion
Group B: Patients with moderate malocclusion
Group C: Patients with severe malocclusion
Group D: Patients with obstructive malocclusion

Trial outcomes

Primary outcomes

1

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.

Time frame
First day
2

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.

Time frame
First day
3

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.

Time frame
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.

Time frame
approximately in the 4th month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: