- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07350681
Effect of Orthognathic Surgery on Plantar Pressure and Posture
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Şerife Şahin, Assistant Professor
Study Contact Backup
- Name: Ayşenur Dindar, PhD student
- Phone Number: +90 5392881190
- Email: aysenur.dindar@hotmail.com
Study Locations
-
-
Fatih
-
Istanbul, Fatih, Turkey (Türkiye), 34093
- Recruiting
- Bezmialem Vakif University Faculty of Dentistry, Department of Orthodontics
-
Contact:
- Ayşenur Dindar, PhD student
- Phone Number: +90 5392881190
- Email: aysenur.dindar@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Orthognathic Surgery Group
Patients undergoing orthognathic surgery with postoperative orthodontic treatment
|
Participants in the experimental group will undergo orthognathic surgery
|
|
No Intervention: Control Group
Control group subjects not undergoing orthognathic surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 6 months postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
|
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
|
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.
|
Baseline & 6 months postoperative
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: AYSENUR DİNDAR, Bezmiâlem Vakıf University, Institute of Health Sciences, Department of Orthodontics, İstanbul, Türkiye
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E.211678
- 20240605E (Other Grant/Funding Number: Bezmialem Vakif University Scientific Research Projects Coordination Unit (BAP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Orthognathic Surgery
-
Cairo UniversityNot yet recruiting
-
Kaohsiung Medical University Chung-Ho Memorial...Completed
-
AZ Sint-Jan AVCompletedOrthognathic SurgeryBelgium
-
AZ Sint-Jan AVCompleted
-
Cairo UniversityUnknown
-
Assistance Publique Hopitaux De MarseilleUnknownOrthognathic SurgeryFrance
-
Yonsei UniversityCompletedOrthognathic SurgeryKorea, Republic of
-
Alexandria UniversityCompletedOrthognathic SurgeryEgypt
-
Cairo UniversityCompleted
-
University Hospital, ToulouseUnknown
Clinical Trials on Orthognathic Surgery
-
Peking Union Medical CollegeCompleted
-
TC Erciyes UniversityCompletedSkeletal Class III DeformityTurkey (Türkiye)
-
Faculty of Dental Medicine for GirlsCompleted
-
University Hospital, ToulouseUnknown
-
Nova Scotia Health AuthorityCompletedDentofacial DeformitiesCanada
-
Lund University HospitalCompletedMalocclusion | OSA | Dentofacial DeformitiesSweden
-
Hospital Carlos Van BurenUniversidad de Valparaiso; University of Chile; Universidad de La Frontera; Hospital... and other collaboratorsCompletedHealth-related Quality of Life | Dentofacial DeformitiesChile
-
Bezmialem Vakif UniversityCompletedRoot Resorption | Class III MalocclusionTurkey
-
Hanoi Medical UniversityCompletedSkeletal Class III MalocclusionVietnam
-
Rio de Janeiro State UniversityRecruitingMalocclusion, Angle Class IIIBrazil