Orthognathic SurgeryNCT07350681
Effect of Orthognathic Surgery on Plantar Pressure and Posture
A study testing Orthognathic Surgery in people with Orthognathic Surgery and Postural Balance, run by Ayşenur Dindar at 1 site in Turkey (Türkiye).
Trial summary
Orthognathic surgery leads to changes in the three-dimensional position of the jaws, which may result in alterations in head and neck posture as well as overall body posture. These postural changes are also expected to influence plantar pressure distribution. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthognathic Surgery, Postural Balance
- What is being tested?
- Orthognathic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Sep 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Study Group (Orthognathic Surgery Group)
- Participants will be eligible for inclusion in the surgical cohort if they meet all of the following criteria:
- Individuals scheduled to undergo single-jaw or double-jaw orthognathic surgery as part of comprehensive orthodontic treatment.
- Currently receiving orthodontic therapy utilizing clear aligner systems or fixed orthodontic appliances.
- Availability of preoperative lateral cephalometric radiographs obtained as part of routine clinical evaluation.
- Age ≥ 18 years at the time of enrollment.
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- Completion of a minimum of 6 months of postoperative orthodontic treatment, enabling standardized follow-up evaluation.
- Body Mass Index (BMI) < 30 kg/m², to minimize confounding effects related to obesity on postural and plantar pressure measurements.
- Control Group (Non-surgical Group)
- Participants will be eligible for inclusion in the control cohort if they meet all of the following criteria:
- Individuals not undergoing orthognathic surgery during the study period.
- Receiving orthodontic treatment with clear aligners or fixed appliances, comparable to the surgical cohort.
- BMI < 30 kg/m².
- Age ≥ 18 years.
- No participation in physical activities or rehabilitative programs that may alter postural parameters or plantar pressure distribution during the study period.
Who cannot join
- Participants from either cohort will be excluded if they exhibit:
- Neuromuscular, musculoskeletal, or postural disorders that may independently influence balance or plantar pressure distribution.
- History of previous orthognathic or maxillofacial surgery.
- Systemic diseases affecting bone metabolism, neuromuscular function, or gait.
- Pregnancy.
- Inability or unwillingness to comply with study procedures or follow-up assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Şerife Şahin, Assistant Professor contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University Faculty of Dentistry, Department of Orthodontics
Istanbul, Fatih, 34093
Ayşenur Dindar, PhD student, +90 5392881190, aysenur.dindar@hotmail.com
About this study
Official title: Evaluation of the Effects of Orthognathic Surgery on Plantar Pressure Distribution and Posture
Orthognathic surgery leads to changes in the three-dimensional position of the jaws, which may result in alterations in head and neck posture as well as overall body posture. These postural changes are also expected to influence plantar pressure distribution. This study aims to evaluate the direction and magnitude of these changes by assessing posture and plantar pressure measurements before and after orthognathic surgery.
Postural analysis and plantar pressure measurements will be performed preoperatively and at the 6-month postoperative follow-up in patients undergoing orthognathic surgery. In order to allow a reliable comparison, a control group consisting of non-operated individuals will also be included. The range of natural changes observed in the control group will be determined, and the outcomes will be compared between the surgical and control groups.
By comparing preoperative and postoperative measurements, this study aims to evaluate the effects of orthognathic surgery on body posture and plantar pressure distribution. The findings are expected to contribute to the identification of parameters that should be considered in postoperative evaluation and rehabilitation. Furthermore, the results will provide valuable information regarding the postural and plantar pressure changes observed in patients following orthognathic surgery.
Read the detailed description
A total of 60 participants will be included in the study, consisting of 30 patients scheduled to undergo orthognathic surgery as the study group and 30 patients who have completed their orthodontic treatment and attend regular follow-up visits as the control group.
In the study group, static and dynamic computerized plantar pressure analyses will be performed preoperatively using a pedobarography system (static analysis with BEVER®, dynamic analysis with PAROMED®). These analyses will be interpreted by a physiotherapist. Total body posture analysis will be performed using the PostureScreen® mobile application. Four-directional photographs of each participant will be taken by the researcher, and posture analysis will be conducted in collaboration with the physiotherapist according to the anatomical landmarks designated by the application. Body height and weight will be measured during routine pre-anesthetic evaluations. Preoperative lateral cephalometric radiographs (PLANMECA®) will be obtained as part of routine clinical records, and cephalometric evaluations will be performed on these images.
At the 6-month postoperative follow-up, body height and weight measurements, lateral cephalometric radiographs, static and dynamic computerized plantar pressure analyses, and total body posture analysis will be repeated in the surgical group. Baseline and follow-up values will be compared to determine the direction and magnitude of changes.
In the control group, in addition to routine lateral cephalometric radiographs obtained at the end of treatment, total body posture analysis using the PostureScreen® mobile application, static and dynamic computerized plantar pressure analyses, and body height and weight measurements will be performed. The same assessments will be repeated at the routine 6-month follow-up visit for the control group participants.
- Conditions
- Orthognathic Surgery, Postural Balance
- Being tested
- Orthognathic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthognathic SurgeryProcedure or surgery
Participants in the experimental group will undergo orthognathic surgery
| Study group | Role | What they receive |
|---|---|---|
| Orthognathic Surgery Group | Experimental | Patients undergoing orthognathic surgery with postoperative orthodontic treatment Receives: Procedure: Orthognathic Surgery |
| Control Group | No intervention | Control group subjects not undergoing orthognathic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plantar Pressure Distribution
Plantar pressure distribution will be evaluated using static and dynamic pedobarographic measurements. Peak plantar pressure, pressure distribution patterns, and contact area will be recorded preoperatively and at 6 months postoperatively to assess changes in plantar loading following orthognathic surgery.
Measured: Baseline and 6 months postoperative
Secondary outcomes (2)
Change in Whole-Body Postural Alignment Measured by PostureScreen® Mobile Application at Baseline and 6 Months Postoperative
Whole-body postural alignment will be quantitatively evaluated using the PostureScreen® mobile application. Digital postural parameters will be recorded preoperatively and at 6 months postoperatively to assess changes in global body posture following orthognathic surgery.
Measured: Preoperative baseline and 6 months postoperative
Change in Cranio-Cervical Posture Measured by Lateral Cephalometric Analysis at Baseline and 6 Months Postoperative
Cranio-cervical posture will be assessed using lateral cephalometric radiographs. Angular cephalometric parameters will be recorded preoperatively. OPT/CVT angle (Odontoid Process Tangent / Cervical Vertebra Tangent angle) will be measured on lateral cephalometric radiographs to evaluate postoperative cranio-cervical postural changes.
Measured: Baseline & 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start29 Sep 2025
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic SurgeryStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayşenur Dindar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayşenur Dindar, Bezmialem Vakif University
- Investigators
- AYSENUR DİNDAR, Principal investigator, Bezmiâlem Vakıf University, Institute of Health Sciences, Department of Orthodontics, İstanbul, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350681
- Sponsor's protocol ID
- E.211678
- Other IDs
- 20240605E
- Status last verified
- Jan 2026
- First submitted
- 14 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Orthognathic Surgery on Plantar Pressure Distribution and Posture
- ClinicalTrials.gov ID
- NCT07350681
- Acronym / sponsor ID
- E.211678
- Conditions
- Orthognathic Surgery, Postural Balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ayşenur DindarUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 20 Jan 2026 (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.
Orthognathic surgery leads to changes in the three-dimensional position of the jaws, which may result in alterations in head and neck posture as well as overall body posture. These postural changes are also expected to influence plantar pressure distribution. This study aims to evaluate the direction and magnitude of these changes by assessing posture and plantar pressure measurements before and after orthognathic surgery.
Postural analysis and plantar pressure measurements will be performed preoperatively and at the 6-month postoperative follow-up in patients undergoing orthognathic surgery. In order to allow a reliable comparison, a control group consisting of non-operated individuals will also be included. The range of natural changes observed in the control group will be determined, and the outcomes will be compared between the surgical and control groups.
By comparing preoperative and postoperative measurements, this study aims to evaluate the effects of orthognathic surgery on body posture and plantar pressure distribution. The findings are expected to contribute to the identification of parameters that should be considered in postoperative evaluation and rehabilitation. Furthermore, the results will provide valuable information regarding the postural and plantar pressure changes observed in patients following orthognathic surgery.
Detailed description
A total of 60 participants will be included in the study, consisting of 30 patients scheduled to undergo orthognathic surgery as the study group and 30 patients who have completed their orthodontic treatment and attend regular follow-up visits as the control group.
In the study group, static and dynamic computerized plantar pressure analyses will be performed preoperatively using a pedobarography system (static analysis with BEVER®, dynamic analysis with PAROMED®). These analyses will be interpreted by a physiotherapist. Total body posture analysis will be performed using the PostureScreen® mobile application. Four-directional photographs of each participant will be taken by the researcher, and posture analysis will be conducted in collaboration with the physiotherapist according to the anatomical landmarks designated by the application. Body height and weight will be measured during routine pre-anesthetic evaluations. Preoperative lateral cephalometric radiographs (PLANMECA®) will be obtained as part of routine clinical records, and cephalometric evaluations will be performed on these images.
At the 6-month postoperative follow-up, body height and weight measurements, lateral cephalometric radiographs, static and dynamic computerized plantar pressure analyses, and total body posture analysis will be repeated in the surgical group. Baseline and follow-up values will be compared to determine the direction and magnitude of changes.
In the control group, in addition to routine lateral cephalometric radiographs obtained at the end of treatment, total body posture analysis using the PostureScreen® mobile application, static and dynamic computerized plantar pressure analyses, and body height and weight measurements will be performed. The same assessments will be repeated at the routine 6-month follow-up visit for the control group participants.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthognathic Surgery Group | Experimental | Procedure: Orthognathic SurgeryPatients undergoing orthognathic surgery with postoperative orthodontic treatment |
| Control Group | No intervention | –Control group subjects not undergoing orthognathic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Study Group (Orthognathic Surgery Group)
- Participants will be eligible for inclusion in the surgical cohort if they meet all of the following criteria:
- Individuals scheduled to undergo single-jaw or double-jaw orthognathic surgery as part of comprehensive orthodontic treatment.
- Currently receiving orthodontic therapy utilizing clear aligner systems or fixed orthodontic appliances.
- Availability of preoperative lateral cephalometric radiographs obtained as part of routine clinical evaluation.
Key exclusion criteria (6 listed)
- Participants from either cohort will be excluded if they exhibit:
- Neuromuscular, musculoskeletal, or postural disorders that may independently influence balance or plantar pressure distribution.
- History of previous orthognathic or maxillofacial surgery.
- Systemic diseases affecting bone metabolism, neuromuscular function, or gait.
- Pregnancy.
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 |
|---|---|---|
| Orthognathic SurgeryParticipants in the experimental group will undergo orthognathic surgery | Procedure or surgery | Orthognathic Surgery Group |
Primary outcome
Change in Plantar Pressure Distribution
Time frame: Baseline and 6 months postoperative
Plantar pressure distribution will be evaluated using static and dynamic pedobarographic measurements. Peak plantar pressure, pressure distribution patterns, and contact area will be recorded preoperatively and at 6 months postoperatively to assess changes in plantar loading following orthognathic surgery.
2 secondary outcomes
Change in Whole-Body Postural Alignment Measured by PostureScreen® Mobile Application at Baseline and 6 Months Postoperative
Time frame: Preoperative baseline and 6 months postoperative
Change in Cranio-Cervical Posture Measured by Lateral Cephalometric Analysis at Baseline and 6 Months Postoperative
Time frame: Baseline & 6 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- 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.
Şerife Şahin, Assistant Professor contact
AYSENUR DİNDAR principal investigator
Bezmiâlem Vakıf University, Institute of Health Sciences, Department of Orthodontics, İstanbul, Türkiye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthognathic Surgery in people with Orthognathic Surgery and Postural Balance, run by Ayşenur Dindar 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 15 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aysenur Dindar, PhD student (+90 5392881190, aysenur.dindar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plantar Pressure Distribution (time frame: Baseline and 6 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2026.