Soft Tissue Changes After Orthognathic Surgery (Orthognathic)

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.

Study Overview

• Status: Completed
• Conditions: Skeletal Class III Deformity
• Intervention / Treatment: Procedure: Minimally Invasive Bimaxillary Orthognathic Surgery; Procedure: Conventional Bimaxillary Orthognathic Surgery

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Kayseri
    • Kayseri, Kayseri, Turkey (Türkiye), 38000
      • Erciyes University Faculty of Dentistry Department of Orthodontics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Minimally Invasive Orthognathic Surgery; 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.	Procedure: Minimally 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.
Active Comparator: Conventional Orthognathic Surgery; Skeletal Class III patients treated with conventional bimaxillary orthognathic surgery. Postoperative soft tissue changes were evaluated using three-dimensional stereophotogrammetric analysis.	Procedure: Conventional Bimaxillary Orthognathic Surgery; Bimaxillary orthognathic surgery performed using conventional surgical exposure and standard soft tissue dissection techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway Measurements	Airway measurements (mm) evaluated using cephalometric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.	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.	Up to 6 months

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Study Director: GOKHAN COBAN, Associate Professor, Erciyes University Faculty of Dentistry

Publications and helpful links

General 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.
• Dinu 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.
• Ajmera 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2025
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): July 10, 2025

Study Registration Dates

• First Submitted: May 10, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Stereophotogrammetry; Bimaxillary orthognathic surgery; Minimally invasive technique; Skeletal Class III
• Other Study ID Numbers: TDH-2024/305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No