Skeletal Class III DeformityOrthognathicNCT07595978
Soft Tissue Changes After Orthognathic Surgery
A study testing Minimally Invasive Bimaxillary Orthognathic Surgery and Conventional Bimaxillary Orthognathic Surgery in people with Skeletal Class III Deformity, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated postoperative soft tissue changes in skeletal Class III patients following minimally invasive and conventional orthognathic surgery using three-dimensional stereophotogrammetric analysis. Read more about this study
- Who is it for?
- Ages 17 to 36 years
- Conditions the study is for
- Skeletal Class III Deformity
- What is being tested?
- Minimally Invasive Bimaxillary Orthognathic Surgery and Conventional Bimaxillary Orthognathic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2025to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 to 36 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Skeletal Class III patients requiring bimaxillary orthognathic surgery Patients treated with minimally invasive or conventional orthognathic surgery Availability of high-resolution three-dimensional stereophotogrammetric images obtained preoperatively and at least 6 months postoperatively Patients with complete clinical records Completion of craniofacial growth Patients with less than 10 mm maxillary advancement/setback
Who cannot join
- Craniofacial syndromes or congenital anomalies History of previous orthognathic surgery Facial trauma affecting soft tissue morphology Incomplete clinical or imaging records Systemic diseases affecting soft tissue healing or craniofacial morphology
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Faculty of Dentistry Department of Orthodontics
Kayseri, Kayseri, 38000
About this study
Official title: Three-Dimensional Stereophotogrammetric Analysis of Soft Tissue Changes Following Minimally Invasive Versus Conventional Orthognathic Surgery in Skeletal Class III Patients
This study evaluated postoperative soft tissue changes in skeletal Class III patients following minimally invasive and conventional orthognathic surgery using three-dimensional stereophotogrammetric analysis.
Read the detailed description
This study was conducted on 31 adult patients who underwent bimaxillary orthognathic surgery. Patients were divided into minimally invasive (n=15; mean age: 23.2 years) and conventional surgery groups (n=16; mean age: 22.4 years) according to the surgical technique performed. High-resolution three-dimensional stereophotogrammetric facial images were obtained preoperatively (T0) and at least six months postoperatively (T1). Three-dimensional displacements of soft tissue anthropometric landmarks, as well as linear and angular measurements, were analyzed. Data distribution was assessed using the Shapiro-Wilk test, and appropriate parametric and non-parametric tests were used for intra- and intergroup comparisons. Statistical significance was set at p<0.05.
- Conditions
- Skeletal Class III Deformity
- Being tested
- Minimally Invasive Bimaxillary Orthognathic Surgery, Conventional Bimaxillary Orthognathic Surgery
- Keywords
- Bimaxillary orthognathic surgery, Minimally invasive technique, Skeletal Class III, Stereophotogrammetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Bimaxillary Orthognathic SurgeryProcedure or surgery
Bimaxillary orthognathic surgery performed using a minimally invasive surgical approach characterized by limited soft tissue dissection, reduced surgical exposure, and preservation of vascular integrity to minimize postoperative soft tissue alterations.
Conventional Bimaxillary Orthognathic SurgeryProcedure or surgery
Bimaxillary orthognathic surgery performed using conventional surgical exposure and standard soft tissue dissection techniques.
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive Orthognathic Surgery | Experimental | Skeletal Class III patients treated with minimally invasive bimaxillary orthognathic surgery characterized by reduced soft tissue dissection, limited surgical exposure, and preservation of vascular integrity compared with the conventional approach. This technique aims to minimize postoperative soft tissue alterations and improve postoperative recovery. Soft tissue changes were evaluated using three-dimensional stereophotogrammetric analysis. Receives: Procedure: Minimally Invasive Bimaxillary Orthognathic Surgery |
| Conventional Orthognathic Surgery | Active comparator | Skeletal Class III patients treated with conventional bimaxillary orthognathic surgery. Postoperative soft tissue changes were evaluated using three-dimensional stereophotogrammetric analysis. Receives: Procedure: Conventional Bimaxillary Orthognathic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-Dimensional Soft Tissue Landmark Displacements
Three-dimensional soft tissue landmark displacements (mm) evaluated using stereophotogrammetric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.
Measured: Up to 6 months
Linear Soft Tissue Measurements
Linear soft tissue measurements (mm) evaluated using stereophotogrammetric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.
Measured: Up to 6 months
Angular Soft Tissue Measurements
Angular soft tissue measurements (degree) evaluated using stereophotogrammetric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.
Measured: Up to 6 months
Secondary outcomes (2)
Airway Measurements
Airway measurements (mm) evaluated using cephalometric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.
Measured: Up to 6 months
Lip Thickness Measurements
Upper and lower lip thickness measurements (mm) evaluated using three-dimensional stereophotogrammetric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start2 Jan 2025
- Primary completion1 Mar 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Skeletal Class III DeformityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study was conducted on 31 adult patients who underwent bimaxillary orthognathic surgery. Patients were divided into minimally invasive (n=15; mean age: 23.2 years) and conventional surgery groups (n=16; mean age: 22.38 years) according to the surgical technique performed. High-resolution three-dimensional stereophotogrammetric facial images were obtained preoperatively (T0) and at least six months postoperatively (T1). Three-dimensional displacements of soft tissue anthropometric landmarks, as well as linear and angular measurements, were analyzed. Data distribution was assessed using the Shapiro-Wilk test, and appropriate parametric and non-parametric tests were used for intra- and intergroup comparisons. Statistical significance was set at p\<0.05.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokhan Coban, TC Erciyes University
- Investigators
- GOKHAN COBAN, Associate Professor, Study director, Erciyes University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595978
- Sponsor's protocol ID
- TDH-2024/305
- Acronym
- Orthognathic
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weinberg SM. 3D stereophotogrammetry versus traditional craniofacial anthropometry: Comparing measurements from the 3D facial norms database to Farkas's North American norms. Am J Orthod Dentofacial Orthop. 2019 May;155(5):693-701. doi: 10.1016/j.ajodo.2018.06.018.
PubMed 31053285Dinu C, Manea A, Tomoiaga D, Baciut M, Almasan O, Mitre AO, Barbur I, Hedesiu M, Armencea G, Opris H, Stoia S, Tamas T, Baciut G, Onisor F, Bran S. Recovery following Orthognathic Surgery Procedures-A Pilot Study. Int J Environ Res Public Health. 2022 Nov 30;19(23):16028. doi: 10.3390/ijerph192316028.
PubMed 36498101Ajmera DH, Singh P, Leung YY, Gu M. Three-dimensional evaluation of soft-tissue response to osseous movement after orthognathic surgery in patients with facial asymmetry: A systematic review. J Craniomaxillofac Surg. 2021 Sep;49(9):763-774. doi: 10.1016/j.jcms.2021.04.010. Epub 2021 Apr 24.
PubMed 34016501
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Dimensional Stereophotogrammetric Analysis of Soft Tissue Changes Following Minimally Invasive Versus Conventional Orthognathic Surgery in Skeletal Class III Patients
- ClinicalTrials.gov ID
- NCT07595978
- Acronym / sponsor ID
- Orthognathic / TDH-2024/305
- Conditions
- Skeletal Class III Deformity
- Keywords
- Bimaxillary orthognathic surgery, Minimally invasive technique, Skeletal Class III, Stereophotogrammetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 19 May 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 evaluated postoperative soft tissue changes in skeletal Class III patients following minimally invasive and conventional orthognathic surgery using three-dimensional stereophotogrammetric analysis.
Detailed description
This study was conducted on 31 adult patients who underwent bimaxillary orthognathic surgery. Patients were divided into minimally invasive (n=15; mean age: 23.2 years) and conventional surgery groups (n=16; mean age: 22.4 years) according to the surgical technique performed. High-resolution three-dimensional stereophotogrammetric facial images were obtained preoperatively (T0) and at least six months postoperatively (T1). Three-dimensional displacements of soft tissue anthropometric landmarks, as well as linear and angular measurements, were analyzed. Data distribution was assessed using the Shapiro-Wilk test, and appropriate parametric and non-parametric tests were used for intra- and intergroup comparisons. Statistical significance was set at p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was conducted on 31 adult patients who underwent bimaxillary orthognathic surgery. Patients were divided into minimally invasive (n=15; mean age: 23.2 years) and conventional surgery groups (n=16; mean age: 22.38 years) according to the surgical technique performed. High-resolution three-dimensional stereophotogrammetric facial images were obtained preoperatively (T0) and at least six months postoperatively (T1). Three-dimensional displacements of soft tissue anthropometric landmarks, as well as linear and angular measurements, were analyzed. Data distribution was assessed using the Shapiro-Wilk test, and appropriate parametric and non-parametric tests were used for intra- and intergroup comparisons. Statistical significance was set at p<0.05.
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Orthognathic Surgery | Experimental | Procedure: Minimally Invasive Bimaxillary Orthognathic SurgerySkeletal Class III patients treated with minimally invasive bimaxillary orthognathic surgery characterized by reduced soft tissue dissection, limited surgical exposure, and preservation of vascular integrity compared with the conventional approach. This technique aims to minimize postoperative soft tissue alterations and improve postoperative recovery. Soft tissue changes were evaluated using three-dimensional stereophotogrammetric analysis. |
| Conventional Orthognathic Surgery | Active comparator | Procedure: Conventional Bimaxillary Orthognathic SurgerySkeletal Class III patients treated with conventional bimaxillary orthognathic surgery. Postoperative soft tissue changes were evaluated using three-dimensional stereophotogrammetric analysis. |
Who may qualify
- Ages
- 17 to 36 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Skeletal Class III patients requiring bimaxillary orthognathic surgery Patients treated with minimally invasive or conventional orthognathic surgery Availability of high-resolution three-dimensional stereophotogrammetric images obtained preoperatively and at least 6 months postoperatively Patients with complete clinical records Completion of craniofacial growth Patients with less than 10 mm maxillary advancement/setback
Key exclusion criteria (1 listed)
- Craniofacial syndromes or congenital anomalies History of previous orthognathic surgery Facial trauma affecting soft tissue morphology Incomplete clinical or imaging records Systemic diseases affecting soft tissue healing or craniofacial morphology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally Invasive Bimaxillary Orthognathic SurgeryBimaxillary orthognathic surgery performed using a minimally invasive surgical approach characterized by limited soft tissue dissection, reduced surgical exposure, and preservation of vascular integrity to minimize postoperative soft tissue alterations. | Procedure or surgery | Minimally Invasive Orthognathic Surgery |
| Conventional Bimaxillary Orthognathic SurgeryBimaxillary orthognathic surgery performed using conventional surgical exposure and standard soft tissue dissection techniques. | Procedure or surgery | Conventional Orthognathic Surgery |
Primary outcome
Three-Dimensional Soft Tissue Landmark Displacements
Time frame: Up to 6 months
Three-dimensional soft tissue landmark displacements (mm) evaluated using stereophotogrammetric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.
Linear Soft Tissue Measurements
Time frame: Up to 6 months
Linear soft tissue measurements (mm) evaluated using stereophotogrammetric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.
Angular Soft Tissue Measurements
Time frame: Up to 6 months
Angular soft tissue measurements (degree) evaluated using stereophotogrammetric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.
2 secondary outcomes
Airway Measurements
Time frame: Up to 6 months
Lip Thickness Measurements
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Background: PubMed 31053285Weinberg SM. 3D stereophotogrammetry versus traditional craniofacial anthropometry: Comparing measurements from the 3D facial norms database to Farkas's North American norms. Am J Orthod Dentofacial Orthop. 2019 May;155(5):693-701. doi: 10.1016/j.ajodo.2018.06.018.
- Background: PubMed 36498101Dinu C, Manea A, Tomoiaga D, Baciut M, Almasan O, Mitre AO, Barbur I, Hedesiu M, Armencea G, Opris H, Stoia S, Tamas T, Baciut G, Onisor F, Bran S. Recovery following Orthognathic Surgery Procedures-A Pilot Study. Int J Environ Res Public Health. 2022 Nov 30;19(23):16028. doi: 10.3390/ijerph192316028.
- Background: PubMed 34016501Ajmera DH, Singh P, Leung YY, Gu M. Three-dimensional evaluation of soft-tissue response to osseous movement after orthognathic surgery in patients with facial asymmetry: A systematic review. J Craniomaxillofac Surg. 2021 Sep;49(9):763-774. doi: 10.1016/j.jcms.2021.04.010. Epub 2021 Apr 24.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
GOKHAN COBAN, Associate Professor study director
Erciyes 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?
A study testing Minimally Invasive Bimaxillary Orthognathic Surgery and Conventional Bimaxillary Orthognathic Surgery in people with Skeletal Class III Deformity, run by TC Erciyes 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-Dimensional Soft Tissue Landmark Displacements (time frame: Up to 6 months). 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?
On the ClinicalTrials.gov record for NCT07595978, which also lists 3 linked publications.
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 19 May 2026.