NCT07702448

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
12mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Jun 2026Jul 2027

Study Start

First participant enrolled

June 20, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2027

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 9, 2026

Last Update Submit

July 15, 2026

Conditions

Keywords

Orthognathic SurgeryBimaxillary SurgeryDentofacial DeformityQuality of LifePsychological OutcomesBeck Depression Inventory-IIRosenberg Self-Esteem ScaleOrthognathic Quality of Life Questionnaire

Outcome Measures

Primary Outcomes (3)

  • Change in Depressive Symptoms

    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

    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

    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

Study Arms (3)

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.

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adult patients aged 18-40 years with different types of malocclusion who are scheduled to undergo bimaxillary orthognathic surgery at the Faculty of Dentistry, Kırıkkale University. Eligible participants will be evaluated 1 week before surgery and 6 months after surgery using validated patient-reported outcome measures assessing depressive symptoms, self-esteem, and orthognathic quality of life.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University Faculty of Dentistry

Kirikkale, Kırıkkale, 71450, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dentofacial DeformitiesMalocclusion

Condition Hierarchy (Ancestors)

Maxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesStomatognathic System AbnormalitiesStomatognathic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesTooth Diseases

Study Officials

  • Elif Çoban, DDS

    Kırıkkale University Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Assistant Professor, DDS

CONTACT

Murat Rıfat Research Asistant, DDS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 14, 2026

Study Start

June 20, 2026

Primary Completion (Estimated)

June 20, 2027

Study Completion (Estimated)

July 20, 2027

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

De-identified individual participant data, including demographic characteristics, social media usage, Beck Depression Inventory-II (BDI-II) scores, Rosenberg Self-Esteem Scale (RSES) scores, and Orthognathic Quality of Life Questionnaire (OQLQ) results, will be made available upon reasonable request to the corresponding author after publication of the study results.

Locations