- ICH GCP
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- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Elif Assistant Professor, DDS
- Numéro de téléphone: 71 +90 318 224 4927
- E-mail: elifcoban@kku.edu.tr
Sauvegarde des contacts de l'étude
- Nom: Murat Rıfat Research Asistant, DDS
- Numéro de téléphone: 7130 +90 318 2244927
- E-mail: muratyalinkilic5@gmail.com
Lieux d'étude
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Kırıkkale
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Kirikkale, Kırıkkale, Turquie (Türkiye), 71450
- Recrutement
- Kırıkkale University Faculty of Dentistry
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Contact:
- Elif Assistant Professor, DDS
- Numéro de téléphone: 71 +90 318 224 4927
- E-mail: elifcoban@kku.edu.tr
-
Contact:
- Murat Rıfat Research Assistan, DDS
- Numéro de téléphone: 7130 +90 318 224 4927
- E-mail: muratyalinkilic5@gmail.com
-
Chercheur principal:
- Elif Çoban, DDS
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Depressive Symptoms
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Elif Çoban, DDS, Kırıkkale University Faculty of Dentistry
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies musculo-squelettiques
- Maladies stomatognathiques
- Maladies dentaires
- Anomalies maxillo-faciales
- Anomalies craniofaciales
- Anomalies musculosquelettiques
- Anomalies du système stomatognathique
- Anomalies congénitales
- Maladies et anomalies congénitales, héréditaires et néonatales
- Malocclusion
- Déformations dentofaciales
Autres numéros d'identification d'étude
- Decision No: 2026.06.35
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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