Determination of the Relationship Between Orthodontic Malocclusion Severity and Salivary Cortisol, Dehydroepiandrosterone and Chromogranin A Levels
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Rosenberg Self-Esteem Scale Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Rosenberg Self-Esteem Scale Score
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Concentration of Cortisol, Dehydroepiandrosterone (DHEA) and Chromogranin A(approximately in the 4th month)
研究者
Dilek KARADOĞAN
Assoc. Prof. Dr.
Recep Tayyip Erdogan University Training and Research Hospital