- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07702448
Changes in Depression and Esthetic Perception After Orthognathic Surgery
Evaluation of Changes in Depressive Symptom Levels and Subjective Esthetic Perception in Patients With Different Types of Malocclusion Following Orthognathic Surgery
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Elif Assistant Professor, DDS
- Número de teléfono: 71 +90 318 224 4927
- Correo electrónico: elifcoban@kku.edu.tr
Copia de seguridad de contactos de estudio
- Nombre: Murat Rıfat Research Asistant, DDS
- Número de teléfono: 7130 +90 318 2244927
- Correo electrónico: muratyalinkilic5@gmail.com
Ubicaciones de estudio
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Kırıkkale
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Kirikkale, Kırıkkale, Turquía (Türkiye), 71450
- Reclutamiento
- Kırıkkale University Faculty of Dentistry
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Contacto:
- Elif Assistant Professor, DDS
- Número de teléfono: 71 +90 318 224 4927
- Correo electrónico: elifcoban@kku.edu.tr
-
Contacto:
- Murat Rıfat Research Assistan, DDS
- Número de teléfono: 7130 +90 318 224 4927
- Correo electrónico: muratyalinkilic5@gmail.com
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Investigador principal:
- Elif Çoban, DDS
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Depressive Symptoms
Periodo de tiempo: 1 week before surgery and 6 months after surgery
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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. |
1 week before surgery and 6 months after surgery
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Change in Quality of Life
Periodo de tiempo: 1 week before surgery and 6 months after surgery
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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. |
1 week before surgery and 6 months after surgery
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Change in Self-Esteem
Periodo de tiempo: 1 week before surgery and 6 months after surgery
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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. |
1 week before surgery and 6 months after surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Elif Çoban, DDS, Kırıkkale University Faculty of Dentistry
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades musculoesqueléticas
- Enfermedades Estomatognáticas
- Enfermedades de los dientes
- Anomalías maxilofaciales
- Anomalías craneofaciales
- Anomalías musculoesqueléticas
- Anomalías del sistema estomatognático
- Anomalías congénitas
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Maloclusión
- Deformidades Dentofaciales
Otros números de identificación del estudio
- Decision No: 2026.06.35
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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