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Soft Tissue Changes After Orthognathic Surgery

Three-Dimensional Stereophotogrammetric Analysis of Soft Tissue Changes Following Minimally Invasive Versus Conventional Orthognathic Surgery in Skeletal Class III Patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07595978
Acronym
Orthognathic
Enrollment
31
Registered
2026-05-19
Start date
2025-01-02
Completion date
2025-07-10
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skeletal Class III Deformity

Keywords

Bimaxillary orthognathic surgery, Minimally invasive technique, Skeletal Class III, Stereophotogrammetry

Brief 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.

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.

Interventions

PROCEDUREMinimally Invasive Bimaxillary Orthognathic 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.

PROCEDUREConventional Bimaxillary Orthognathic Surgery

Bimaxillary orthognathic surgery performed using conventional surgical exposure and standard soft tissue dissection techniques.

Sponsors

TC Erciyes University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
17 Years to 36 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Three-Dimensional Soft Tissue Landmark DisplacementsUp to 6 monthsThree-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 MeasurementsUp to 6 monthsLinear soft tissue measurements (mm) evaluated using stereophotogrammetric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.
Angular Soft Tissue MeasurementsUp to 6 monthsAngular soft tissue measurements (degree) evaluated using stereophotogrammetric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.

Secondary

MeasureTime frameDescription
Airway MeasurementsUp to 6 monthsAirway measurements (mm) evaluated using cephalometric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.
Lip Thickness MeasurementsUp to 6 monthsUpper 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.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORGOKHAN COBAN, Associate Professor

Erciyes University Faculty of Dentistry

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026