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CompletedNCT06873451Updated Mar 9, 2026

Effects of Orthognathic Surgery on Root Resorption and Soft Tissues

An interventional study of Surgery First and Surgery Early in Orthodontics and Orthognathic Surgical Procedures, sponsored by Gokhan Coban. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by Gokhan Coban · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Oct 2023, registered Feb 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Orthodontics
  • Orthognathic Surgical Procedures

Keywords

  • Orthognathic surgery
  • Surgery first
  • surgery early
  • dehiscence
  • Fenestration
03

In context

Lead sponsor

This is the only study on the registry with Gokhan Coban as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • History of trauma,
  • Congenital anomalies or craniofacial deformities
  • Congenital tooth loss (excluding wisdom teeth)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureSurgery 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.

  • ProcedureSurgery 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.

06

What researchers measure

Primary outcomes

  1. Tooth length measurement (mm)

    Root length of maxillary incisors will be measured using cone-beam computed tomography (CBCT). Data will be reported as mean change (± SD).

    Time frame: up to 15 months

  2. Tooth volume measurement (mm^3)

    Root volume of maxillary incisors will be measured using cone-beam computed tomography (CBCT). Data will be reported as mean change (± SD).

    Time frame: up to 15 months

Secondary outcomes

  1. Soft tissue measurement (3D)

    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).

    Time frame: up to 15 months

07

Study locations

1 site
  • Erciyes University Faculty of Dentistry Department of Orthodontics
    Kayseri, Melikgazi 38000, Turkey (Türkiye)
08

References and documents

Publications

  • Juggins KJ, Nixon F, Cunningham SJ. Patient- and clinician-perceived need for orthognathic surgery. Am J Orthod Dentofacial Orthop. 2005 Dec;128(6):697-702. doi: 10.1016/j.ajodo.2004.09.022. PubMed 16360908 ↗
  • Hernandez-Alfaro F, Guijarro-Martinez R. On a definition of the appropriate timing for surgical intervention in orthognathic surgery. Int J Oral Maxillofac Surg. 2014 Jul;43(7):846-55. doi: 10.1016/j.ijom.2014.02.007. Epub 2014 Mar 13. PubMed 24631424 ↗
  • Millesi GA, Zimmermann M, Eltz M. Surgery First and Surgery Early Treatment Approach in Orthognathic Surgery. Oral Maxillofac Surg Clin North Am. 2023 Feb;35(1):71-82. doi: 10.1016/j.coms.2022.06.010. Epub 2022 Nov 3. PubMed 36336597 ↗
  • Hernandez-Alfaro F, Guijarro-Martinez R, Molina-Coral A, Badia-Escriche C. "Surgery first" in bimaxillary orthognathic surgery. J Oral Maxillofac Surg. 2011 Jun;69(6):e201-7. doi: 10.1016/j.joms.2011.01.010. Epub 2011 Apr 5. No abstract available. PubMed 21470740 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06873451
Lead sponsor
Gokhan Coban
Collaborators
TC Erciyes University
Responsible party
Gokhan Coban (ASSOC. PROF. DR., TC Erciyes University) — Sponsor-investigator
First posted
Mar 12, 2025
Start date
Oct 15, 2023
Primary completion
Aug 25, 2025
Completion
Aug 26, 2025
Last update
Mar 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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