NCT06873451

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2025

Completed
Last Updated

March 9, 2026

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

February 13, 2025

Last Update Submit

March 5, 2026

Conditions

OrthodonticsOrthognathic Surgical Procedures

Keywords

Orthognathic surgerySurgery firstsurgery earlydehiscenceFenestration

Outcome Measures

Primary Outcomes (2)

  • 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).

    up to 15 months

  • 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).

    up to 15 months

Secondary Outcomes (1)

  • Soft tissue measurement (3D)

    up to 15 months

Study Arms (2)

Surgery First

EXPERIMENTAL

Patients in this group started with surgical treatment directly without receiving orthodontic treatment and started orthodontic treatment after surgery.

Procedure: Surgery First

Surgery Early

EXPERIMENTAL

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

Surgery FirstPROCEDURE

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.

Surgery First
Surgery EarlyPROCEDURE

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.

Surgery Early

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Faculty of Dentistry Department of Orthodontics

Kayseri, Melikgazi, 38000, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 16360908BACKGROUND

  • 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.

    PMID: 24631424BACKGROUND

  • 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.

    PMID: 36336597BACKGROUND

  • 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.

    PMID: 21470740BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
ASSOC. PROF. DR.

Study Record Dates

First Submitted

February 13, 2025

First Posted

March 12, 2025

Study Start

October 15, 2023

Primary Completion

August 25, 2025

Study Completion

August 26, 2025

Last Updated

March 9, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)