- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Elif Assistant Professor, DDS
- Numer telefonu: 71 +90 318 224 4927
- E-mail: elifcoban@kku.edu.tr
Kopia zapasowa kontaktu do badania
- Nazwa: Murat Rıfat Research Asistant, DDS
- Numer telefonu: 7130 +90 318 2244927
- E-mail: muratyalinkilic5@gmail.com
Lokalizacje studiów
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Kırıkkale
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Kirikkale, Kırıkkale, Turcja (Türkiye), 71450
- Rekrutacyjny
- Kırıkkale University Faculty of Dentistry
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Kontakt:
- Elif Assistant Professor, DDS
- Numer telefonu: 71 +90 318 224 4927
- E-mail: elifcoban@kku.edu.tr
-
Kontakt:
- Murat Rıfat Research Assistan, DDS
- Numer telefonu: 7130 +90 318 224 4927
- E-mail: muratyalinkilic5@gmail.com
-
Główny śledczy:
- Elif Çoban, DDS
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Depressive Symptoms
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Elif Çoban, DDS, Kırıkkale University Faculty of Dentistry
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu mięśniowo-szkieletowego
- Choroby Stomatognatyczne
- Choroby zębów
- Nieprawidłowości szczękowo-twarzowe
- Nieprawidłowości twarzoczaszki
- Nieprawidłowości mięśniowo-szkieletowe
- Nieprawidłowości układu stomatognatycznego
- Wady wrodzone
- Wrodzone, dziedziczne i noworodkowe choroby i nieprawidłowości
- Wady zgryzu
- Deformacje zębowo-twarzowe
Inne numery identyfikacyjne badania
- Decision No: 2026.06.35
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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