Soft Tissue Changes After Orthognathic Surgery

NCT07595978 | Completed

• 1 other identifier: TDH-2024/305
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Skeletal Class III Deformity

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Airway Measurements

  Up to 6 months

• Lip Thickness Measurements

  Up to 6 months

Study Arms (2)

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.

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.

Procedure: Conventional Bimaxillary Orthognathic Surgery

Interventions

Minimally Invasive Bimaxillary Orthognathic Surgery PROCEDURE

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.

Minimally Invasive Orthognathic Surgery

Conventional Bimaxillary Orthognathic Surgery PROCEDURE

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

Conventional Orthognathic Surgery

Eligibility Criteria

• Age: 17 Years - 36 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Dentistry Department of Orthodontics

Kayseri, Kayseri, 38000, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 31053285 BACKGROUND

• 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.

  PMID: 36498101 BACKGROUND

• 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.

  PMID: 34016501 BACKGROUND

Study Officials

• GOKHAN COBAN, Associate Professor

  Erciyes University Faculty of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 19, 2026
• Study Start: January 2, 2025
• Primary Completion: March 1, 2025
• Study Completion: July 10, 2025
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)