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Completed

NCT Number: NCT07595978

Soft Tissue Changes After Orthognathic Surgery

This study evaluated postoperative soft tissue changes in skeletal Class III patients following minimally invasive and conventional orthognathic surgery using three-dimensional stereophotogrammetric analysis.

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Key information

Age range

17 year–36 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University Faculty of Dentistry Department of Orthodontics

Kayseri, 38000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Conventional Bimaxillary Orthognathic Surgery

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Airway Measurements

    Time frame: Up to 6 months

    Airway measurements (mm) evaluated using cephalometric analysis in skeletal Class III patients undergoing minimally invasive and conventional bimaxillary orthognathic surgery.

  2. Lip Thickness Measurements

    Time frame: Up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Acronym: Orthognathic

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.