- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Elif Assistant Professor, DDS
- Telefoonnummer: 71 +90 318 224 4927
- E-mail: elifcoban@kku.edu.tr
Studie Contact Back-up
- Naam: Murat Rıfat Research Asistant, DDS
- Telefoonnummer: 7130 +90 318 2244927
- E-mail: muratyalinkilic5@gmail.com
Studie Locaties
-
-
Kırıkkale
-
Kirikkale, Kırıkkale, Turkije (Türkiye), 71450
- Werving
- Kırıkkale University Faculty of Dentistry
-
Contact:
- Elif Assistant Professor, DDS
- Telefoonnummer: 71 +90 318 224 4927
- E-mail: elifcoban@kku.edu.tr
-
Contact:
- Murat Rıfat Research Assistan, DDS
- Telefoonnummer: 7130 +90 318 224 4927
- E-mail: muratyalinkilic5@gmail.com
-
Hoofdonderzoeker:
- Elif Çoban, DDS
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Depressive Symptoms
Tijdsspanne: 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. |
1 week before surgery and 6 months after surgery
|
|
Change in Quality of Life
Tijdsspanne: 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. |
1 week before surgery and 6 months after surgery
|
|
Change in Self-Esteem
Tijdsspanne: 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. |
1 week before surgery and 6 months after surgery
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Elif Çoban, DDS, Kırıkkale University Faculty of Dentistry
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Musculoskeletale aandoeningen
- Stomatognatische ziekten
- Tand ziekten
- Maxillofaciale afwijkingen
- Craniofaciale afwijkingen
- Musculoskeletale afwijkingen
- Afwijkingen van het stomatognathische systeem
- Aangeboren afwijkingen
- Aangeboren, erfelijke en neonatale ziekten en afwijkingen
- Malocclusie
- Dentofaciale misvormingen
Andere studie-ID-nummers
- Decision No: 2026.06.35
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .