OrthodonticsNCT06873451
Effects of Orthognathic Surgery on Root Resorption and Soft Tissues
A study testing Surgery First and Surgery Early in people with Orthodontics and Orthognathic Surgical Procedures, run by Gokhan Coban at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthodontics, Orthognathic Surgical Procedures
- What is being tested?
- Surgery First and Surgery Early
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2023to 26 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of trauma,
- Congenital anomalies or craniofacial deformities
- Congenital tooth loss (excluding wisdom teeth)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Faculty of Dentistry Department of Orthodontics
Kayseri, Melikgazi, 38000
About this study
Official title: 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.
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.
- Conditions
- Orthodontics, Orthognathic Surgical Procedures
- Being tested
- Surgery First, Surgery Early
- Keywords
- Orthognathic surgery, Surgery first, surgery early, dehiscence, Fenestration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery FirstProcedure or surgery
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 EarlyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgery First | Experimental | Patients in this group started with surgical treatment directly without receiving orthodontic treatment and started orthodontic treatment after surgery. Receives: 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. Receives: Procedure: Surgery Early |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start15 Oct 2023
- Primary completion25 Aug 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OrthodonticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gokhan Coban
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University
- Responsible party
- Sponsor-investigator, Gokhan Coban, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873451
- Sponsor's protocol ID
- 2023-655
- Status last verified
- Sep 2025
- First submitted
- 13 Feb 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 16360908Hernandez-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 24631424Millesi 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 36336597Hernandez-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
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Comparison Effects of Two Different Surgical Timings in Orthognathic Surgery on Root Resorption and Soft Tissues: Surgery First vs. Surgery Early
- ClinicalTrials.gov ID
- NCT06873451
- Acronym / sponsor ID
- 2023-655
- Conditions
- Orthodontics, Orthognathic Surgical Procedures
- Keywords
- Orthognathic surgery, Surgery first, surgery early, dehiscence, Fenestration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gokhan CobanUniversity, hospital or other
- Collaborators
- TC Erciyes University
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery First | Experimental | Procedure: Surgery FirstPatients in this group started with surgical treatment directly without receiving orthodontic treatment and started orthodontic treatment after surgery. |
| Surgery Early | Experimental | Procedure: Surgery EarlyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (3 listed)
- History of trauma,
- Congenital anomalies or craniofacial deformities
- Congenital tooth loss (excluding wisdom teeth)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery FirstOne 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. | Procedure or surgery | Surgery First |
| Surgery EarlyThe 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. | Procedure or surgery | Surgery Early |
Primary outcome
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).
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).
1 secondary outcome
Soft tissue measurement (3D)
Time frame: up to 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Background: PubMed 16360908Juggins 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.
- Background: PubMed 24631424Hernandez-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.
- Background: PubMed 36336597Millesi 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.
- Background: PubMed 21470740Hernandez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery First and Surgery Early in people with Orthodontics and Orthognathic Surgical Procedures, run by Gokhan Coban at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tooth length measurement (mm) (time frame: up to 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06873451, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.