Dentofacial DeformitiesNCT07702448
Changes in Depression and Esthetic Perception After Orthognathic Surgery
An observational study of Dentofacial Deformities and Malocclusions, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Dentofacial Deformities, Malocclusions, Orthognathic Surgery
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2026to 20 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kırıkkale University Faculty of Dentistry
Kirikkale, Kırıkkale, 71450
Elif Assistant Professor, DDS, +90 318 224 4927 ext. 71, elifcoban@kku.edu.tr
Murat Rıfat Research Assistan, DDS, +90 318 224 4927 ext. 7130, muratyalinkilic5@gmail.com
About this study
Official title: Evaluation of Changes in Depressive Symptom Levels and Subjective Esthetic Perception in Patients With Different Types of Malocclusion Following Orthognathic Surgery
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.
Read the detailed description
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.
- Conditions
- Dentofacial Deformities, Malocclusions, Orthognathic Surgery
- Keywords
- Orthognathic Surgery, Bimaxillary Surgery, Dentofacial Deformity, Quality of Life, Psychological Outcomes, Beck Depression Inventory-II, Rosenberg Self-Esteem Scale, Orthognathic Quality of Life Questionnaire
- Medical subject headings
- Dentofacial Deformities, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 week before surgery and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start20 Jun 2026
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentofacial DeformitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Çoban, Kırıkkale University
- Investigators
- Elif Çoban, DDS, Principal investigator, Kırıkkale University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702448
- Sponsor's protocol ID
- Decision No: 2026.06.35
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Depressive Symptom Levels and Subjective Esthetic Perception in Patients With Different Types of Malocclusion Following Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT07702448
- Acronym / sponsor ID
- Decision No: 2026.06.35
- Conditions
- Dentofacial Deformities, Malocclusions, Orthognathic Surgery
- Keywords
- Orthognathic Surgery, Bimaxillary Surgery, Dentofacial Deformity, Quality of Life, Psychological Outcomes, Beck Depression Inventory-II, Rosenberg Self-Esteem Scale, Orthognathic Quality of Life Questionnaire
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Depressive Symptoms
Time frame: 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.
Change in Quality of Life
Time frame: 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.
Change in Self-Esteem
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Dentofacial Deformities
RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Quantitative Evaluation of Attention to Faces After Orthognathic Surgery With Eye-tracking
Dentofacial Deformities, Orthognathic Surgery
Not yet recruiting
Clinical and Radiographic Evaluation of Low Sagittal Medial Ramus Osteotomy for Treatment of Skeletal Class II and Class III Malocclusion
Skeletal Class II Malocclusion, Skeletal Class III Malocclusion
Active, not recruitingObservational study
Comparative Evaluation of Functional and Aesthetic Outcomes of Box and Mini-Wing Genioplasty Techniques
Class II Malocclusion, Dentofacial Deformities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elif Çoban, DDS principal investigator
Kırıkkale University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dentofacial Deformities and Malocclusions, run by Kırıkkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elif Assistant Professor, DDS (+90 318 224 4927 ext. 71, elifcoban@kku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptoms (time frame: 1 week before surgery and 6 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.