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临床试验/NCT07702448
NCT07702448招募中不适用

Evaluation of Changes in Depressive Symptom Levels and Subjective Esthetic Perception in Patients With Different Types of Malocclusion Following Orthognathic Surgery

Kırıkkale University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
18
试验地点
1
主要终点
Change in Depressive Symptoms

研究概览

简要总结

This study aims to evaluate changes in depressive symptoms and subjective esthetic perception before and after bimaxillary orthognathic surgery in patients with different types of malocclusion. The study will analyze anonymized clinical data and questionnaire responses to assess the impact of orthognathic surgery on psychological well-being and esthetic perception.

详细描述

This prospective observational study aims to investigate changes in depressive symptoms and subjective esthetic perception in patients with different types of malocclusion undergoing bimaxillary orthognathic surgery. Participants will be evaluated before surgery and during the postoperative follow-up using validated assessment questionnaires.

The study will analyze anonymized data obtained from routine clinical records and patient-reported questionnaires. Variables to be collected include age, sex, occupation, educational level, social media use, and patients' subjective perceptions of esthetics and depressive symptoms. The findings will contribute to a better understanding of the psychological and esthetic outcomes associated with orthognathic surgery and may help optimize patient evaluation and treatment planning.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 to 40 years.
  • Individuals without systemic diseases.
  • Patients with an indication for bimaxillary orthognathic surgery.
  • Patients who complete the study questionnaires 1 week before surgery and 6 months after surgery.
  • Individuals who use at least one of the following social media platforms: Instagram, WhatsApp, Snapchat, X, TikTok, or Telegram.
  • Individuals who provide written informed consent to participate in the study.
  • Patients scheduled to undergo treatment at the Faculty of Dentistry, Kırıkkale University.

排除标准

  • Patients without an indication for bimaxillary orthognathic surgery or those undergoing single-jaw surgery only.
  • Individuals with systemic diseases (e.g., diabetes mellitus, hypertension, or thyroid disorders).
  • Patients with a diagnosed psychiatric disorder.
  • Patients with a history of previous orthognathic surgery.
  • Patients scheduled to undergo additional esthetic procedures (e.g., genioplasty, botulinum toxin injection, or dermal filler treatment).
  • Individuals who decline to participate or do not provide written informed consent.

研究组 & 干预措施

Skeletal Class I Malocclusion

Participants with skeletal Class I malocclusion undergoing bimaxillary orthognathic surgery. Changes in depressive symptoms, self-esteem, esthetic perception, and orthognathic quality of life will be evaluated before and after surgery.

Skeletal Class II Malocclusion

Participants with skeletal Class II malocclusion undergoing bimaxillary orthognathic surgery. Changes in depressive symptoms, self-esteem, esthetic perception, and orthognathic quality of life will be evaluated before and after surgery.

Skeletal Class III Malocclusion

Participants with skeletal Class III malocclusion undergoing bimaxillary orthognathic surgery. Changes in depressive symptoms, self-esteem, esthetic perception, and orthognathic quality of life will be evaluated before and after surgery.

结局指标

主要结局

Change in Depressive Symptoms

时间窗: 1 week before surgery and 6 months after surgery

Change in depressive symptom scores measured using the Beck Depression Inventory-II (BDI-II) between the preoperative assessment (1 week before surgery) and the postoperative assessment (6 months after surgery). BDI-II is a 21-item self-report instrument used to assess the severity of depressive symptoms. Each item is scored on a scale from 0 to 3, yielding a total score ranging from 0 to 63. Higher total scores indicate greater severity of self-reported depressive symptoms. BDI-II total scores are interpreted as follows: 0-13 indicates minimal, 14-19 mild, 20-28 moderate, and 29-63 severe levels of depressive symptoms.

Change in Quality of Life

时间窗: 1 week before surgery and 6 months after surgery

Change in quality of life measured using the Orthognathic Quality of Life Questionnaire (OQLQ) between the preoperative assessment (1 week before surgery) and the postoperative assessment (6 months after surgery). OQLQ is a 22-item self-report instrument developed to assess the impact of dentofacial deformities on patients' quality of life. Each item is scored on a scale from 0 to 4, where a score of 0 indicates that the relevant condition does not bother the patient, while higher scores reflect increasing levels of concern. The item scores are summed to obtain a total score ranging from 0 to 88. Higher total scores indicate a greater negative impact of dentofacial deformity on quality of life and, consequently, poorer quality of life, whereas lower scores indicate better quality of life.

Change in Self-Esteem

时间窗: 1 week before surgery and 6 months after surgery

Change in self-esteem scores measured using the Rosenberg Self-Esteem Scale (RSES) between the preoperative assessment (1 week before surgery) and the postoperative assessment (6 months after surgery). RSES is a 10-item self-report instrument developed to assess individuals' global self-esteem and overall sense of self-worth. The scale consists of five positively worded and five negatively worded items, with responses rated on a four-point scale. In the Turkish version adapted by Çuhadaroğlu, responses are evaluated using a Guttman-based scoring system, yielding a total score ranging from 0 to 6. Higher total scores indicate lower levels of self-esteem, whereas lower scores indicate higher levels of self-esteem. Total scores are interpreted as follows: 0-1 indicates high, 2-4 moderate, and 5-6 low levels of self-esteem.

次要结局

未报告次要终点

研究者

发起方
Kırıkkale University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elif Çoban

Assistant Professor

Kırıkkale University

研究点 (1)

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