- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07664059
Postural Assessment in Patients With Malocclusions
Postural Assessment Using 3D Spine Analysis in Patients With Malocclusions
Study Overview
Status
Detailed Description
This observational cross-sectional study aims to evaluate the association between skeletal malocclusions and postural parameters assessed through three-dimensional postural analysis. Patients will be consecutively recruited according to predefined inclusion and exclusion criteria. Written informed consent will be obtained from all participants or from parents/legal guardians in the case of minors prior to enrolment.
For each participant, demographic and clinical data will be collected using a standardized Case Report Form (CRF). Orthodontic assessment will include lateral cephalometric radiography performed as part of routine clinical practice. Cephalometric analysis will be carried out to evaluate sagittal skeletal relationships through the measurement of Sella-Nasion-A Point, Sella-Nasion-B Point, and A Point-Nasion-B Point angles, allowing classification of skeletal malocclusion into Class I, Class II, or Class III. The presence and severity of temporomandibular disorders will also be evaluated using the Helkimo index as part of the routine orthodontic diagnostic assessment.
All participants will subsequently undergo a three-dimensional postural assessment using the Spine 3D system, a rasterstereography-based technology that enables non-invasive, radiation-free evaluation of spinal alignment and global body posture. The system provides quantitative analysis of several postural parameters, including thoracic kyphotic angle, lumbar lordosis angle, cervical curvature, trunk inclination, pelvic rotation, lateral spinal deviations, scapular symmetry, and pelvic symmetry.
The primary outcome of the study will be the thoracic kyphotic angle measured with the Spine 3D system. Secondary outcomes will include the remaining postural parameters, cephalometric measurements, and temporomandibular disorder assessment scores.
No experimental intervention or modification of standard clinical practice will be performed, as all procedures are observational and non-invasive. Statistical analysis will be conducted to evaluate the association between skeletal malocclusion classes, cephalometric variables, temporomandibular disorders, and postural parameters.
Sample size was calculated considering the thoracic kyphotic angle as the primary outcome. The calculation was based on data reported by Parrini et al. (2018), with a reference population mean of 49.24, an expected mean value of 47.41, a standard deviation of 5.24, α = 0.05, and power = 80%. Therefore, a minimum of 64 participants was required for the study.
Statistical analysis will be conducted with R software (R version 3.1.3, R Foundation for Statistical Computing, Vienna, Austria). Descriptive statistics will be calculated for all variables, including mean, standard deviation, median, minimum value, and maximum value. Linear regression analyses will be performed to evaluate the association between postural parameters, skeletal malocclusions, and temporomandibular disorders. Significance for all statistical tests will be predetermined at p < 0.05.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Maria Gloria Nardi, Dr.
- Phone Number: 3386526714
- Email: mariagloria.nardi01@universitadipavia.it
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients referred for orthodontic evaluation
- Presence of skeletal malocclusion
- Availability of lateral cephalometric radiograph
- Ability to undergo three-dimensional postural assessment using the Spine 3D system
- Patients of any age and sex
- Provision of written informed consent by the participant or by parents/legal guardians in case of minors
Exclusion Criteria:
- Previous orthodontic treatment
- Previous orthopaedic treatment affecting posture
- Presence of craniofacial syndromes or congenital anomalies
- History of spinal surgery
- Significant musculoskeletal disorders
- Neurological conditions affecting posture
- Use of medications affecting musculoskeletal function
- Inability to undergo postural assessment
- Lack of written informed consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thoracic kyphotic angle
Time Frame: Baseline
|
The thoracic kyphotic angle will be measured using the Spine 3D system, a non-invasive rasterstereography-based device for three-dimensional postural assessment.
The parameter will be expressed in degrees and used to evaluate sagittal spinal alignment.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lumbar lordosis angle
Time Frame: Baseline
|
The lumbar lordosis angle will be measured using the Spine 3D system and expressed in degrees.
|
Baseline
|
|
Cervical curvature
Time Frame: Baseline
|
Cervical curvature will be assessed using the Spine 3D system as part of the three-dimensional postural evaluation.
|
Baseline
|
|
Trunk inclination
Time Frame: Baseline
|
Trunk inclination will be measured using the Spine 3D system and expressed as a quantitative postural parameter.
|
Baseline
|
|
Pelvic rotation
Time Frame: Baseline
|
Pelvic rotation will be assessed using the Spine 3D system and recorded as a quantitative postural parameter.
|
Baseline
|
|
Lateral spinal deviations
Time Frame: Baseline
|
Lateral spinal deviations will be evaluated using the Spine 3D system to assess frontal plane postural asymmetries.
|
Baseline
|
|
Scapular symmetry
Time Frame: Baseline
|
Scapular symmetry will be assessed using the Spine 3D system as part of the postural analysis.
|
Baseline
|
|
Pelvic symmetry
Time Frame: Baseline
|
Pelvic symmetry will be assessed using the Spine 3D system as part of the postural analysis.
|
Baseline
|
|
Sella-Nasion-A Point angle
Time Frame: Baseline
|
The Sella-Nasion-A Point angle will be calculated using the lateral cephalometric radiograph to assess the anteroposterior position of the maxilla.
|
Baseline
|
|
Sella-Nasion-B Point angle
Time Frame: Baseline
|
The Sella-Nasion-B Point angle will be calculated using the lateral cephalometric radiograph to assess the anteroposterior position of the mandible.
|
Baseline
|
|
A Point-Nasion-B Point angle
Time Frame: Baseline
|
The A Point-Nasion-B Point angle will be calculated using the lateral cephalometric radiograph to assess the sagittal skeletal relationship between the maxilla and mandible.
|
Baseline
|
|
Temporomandibular disorders
Time Frame: Baseline
|
Presence and severity of temporomandibular disorders will be assessed using the Helkimo index.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
- 2026-POSTUREOCCLUSION
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.
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