Effects of Orthognathic Surgery on Root Resorption and Soft Tissues

March 5, 2026 updated by: Gokhan Coban

3D Comparison Effects of Two Different Surgical Timings in Orthognathic Surgery on Root Resorption and Soft Tissues: Surgery First vs. Surgery Early

The aim of this study is to evaluate the three-dimensional tomographic and photographic evaluation of the provision of two different orthognathic surgeries on hard and soft tissues with informative Class III deformity due to maxillary retrognathia and mandibular prognathia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who will undergo non-extraction surgery will be randomized as 'Pre-Surgery' (SEC) and 'Early Surgery' (EC). Maxillary advancement and mandibular recession will be calculated and a total of 24 patients, 12 in each group, will be included in the study. Millimetric (length, dehiscence, fenestration) and volumetric measurements and soft tissue anthropometric points will be measured in three-dimensional recordings taken at the beginning of treatment (T0) and after debonding (T1). Cone beam computed tomography (CBCT) images will be transferred to NNT and 'Mimics 18.0' programs for measurements. Three-dimensional photographs will be evaluated in the 3dMDvultus program. Shapiro-Wilk test will be used for normality, 'two independent samples t-test' and 'Mann Whitney U test' will be used for intra-group and inter-group comparisons.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • They must be over 18 years of age,
  • Skeletal Class III malocclusion and need double jaw orthognathic surgery,
  • Minimum crowding (patients with crowding between 0-3 mm),
  • Complete 3D records before surgery and at the end of treatment,
  • No decay on their teeth,
  • Good oral hygiene,
  • Healthy periodontal tissues.

Exclusion Criteria:

  • History of trauma,
  • Congenital anomalies or craniofacial deformities
  • Congenital tooth loss (excluding wisdom teeth)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgery First
Patients in this group started with surgical treatment directly without receiving orthodontic treatment and started orthodontic treatment after surgery.
Procedure: Surgery First
One month after surgery, patients were called for an appointment and lower and upper brackets were placed. Treatment was completed when right-left Class I canine and molar relationships and ideal overjet and overbite relationships were achieved.
Experimental: Surgery Early
Patients in this group were referred to orthognathic surgery after receiving orthodontic treatment for an average of 6-8 months, and their orthodontic treatments continued after surgery.
Procedure: Surgery Early
The patients were directed to surgery with the upper and lower bonds applied at their first appointment and the brackets in their mouths. After surgery, treatment continued until the right-left Class I canine and molar relationship and the ideal overjet and overbite relationship were achieved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth length measurement (mm)
Time Frame: up to 15 months
Root length of maxillary incisors will be measured using cone-beam computed tomography (CBCT). Data will be reported as mean change (± SD).
up to 15 months
Tooth volume measurement (mm^3)
Time Frame: up to 15 months
Root volume of maxillary incisors will be measured using cone-beam computed tomography (CBCT). Data will be reported as mean change (± SD).
up to 15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue measurement (3D)
Time Frame: up to 15 months
Three-dimensional stereophotogrammetry will be used to assess changes in facial soft tissue profile, including convexity and lip-chin relationships. Results will be summarized as mean changes (± SD).
up to 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gokhan Coban

Collaborators

TC Erciyes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2023

Primary Completion (Actual)

August 25, 2025

Study Completion (Actual)

August 26, 2025

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 12, 2025

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-655

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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