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Postural Assessment in Patients With Malocclusions

Postural Assessment Using 3D Spine Analysis in Patients With Malocclusions

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07664059
Enrollment
64
Registered
2026-06-23
Start date
2026-09-01
Completion date
2028-09-30
Last updated
2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion, Postural; Defect, Temporomandibular Disorder

Brief summary

This observational cross-sectional study aims to investigate the association between skeletal malocclusions and body posture using three-dimensional postural analysis. Patients will undergo cephalometric assessment, temporomandibular disorder evaluation using the Helkimo index, and non-invasive postural evaluation using the Spine 3D system, based on rasterstereography technology. Postural parameters, including thoracic kyphosis, lumbar lordosis, trunk inclination, pelvic asymmetry, and spinal deviations, will be analysed in relation to skeletal malocclusion classes and temporomandibular disorders. The study seeks to improve the understanding of the potential interactions between the stomatognathic system and global body posture and to support a multidisciplinary diagnostic approach in orthodontic patients.

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.

Interventions

RADIATIONLateral teleradiography

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.

OTHERTemporomandibular assessment with Helkimo Index

The presence and severity of temporomandibular disorders will also be evaluated using the Helkimo index as part of the routine orthodontic diagnostic assessment.

OTHERThree-dimensional postural 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.

Sponsors

Andrea Scribante
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Thoracic kyphotic angleBaselineThe 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.

Secondary

MeasureTime frameDescription
Lumbar lordosis angleBaselineThe lumbar lordosis angle will be measured using the Spine 3D system and expressed in degrees.
Cervical curvatureBaselineCervical curvature will be assessed using the Spine 3D system as part of the three-dimensional postural evaluation.
Trunk inclinationBaselineTrunk inclination will be measured using the Spine 3D system and expressed as a quantitative postural parameter.
Pelvic rotationBaselinePelvic rotation will be assessed using the Spine 3D system and recorded as a quantitative postural parameter.
Lateral spinal deviationsBaselineLateral spinal deviations will be evaluated using the Spine 3D system to assess frontal plane postural asymmetries.
Scapular symmetryBaselineScapular symmetry will be assessed using the Spine 3D system as part of the postural analysis.
Pelvic symmetryBaselinePelvic symmetry will be assessed using the Spine 3D system as part of the postural analysis.
Sella-Nasion-A Point angleBaselineThe Sella-Nasion-A Point angle will be calculated using the lateral cephalometric radiograph to assess the anteroposterior position of the maxilla.
Sella-Nasion-B Point angleBaselineThe Sella-Nasion-B Point angle will be calculated using the lateral cephalometric radiograph to assess the anteroposterior position of the mandible.
A Point-Nasion-B Point angleBaselineThe 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.
Temporomandibular disordersBaselinePresence and severity of temporomandibular disorders will be assessed using the Helkimo index.

Contacts

CONTACTMaria Gloria Nardi, Dr.
mariagloria.nardi01@universitadipavia.it3386526714

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026