An observational study in Malocclusion, Temporomandibular Disorder and Postural; Defect, sponsored by Andrea Scribante. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Andrea Scribante · Observational
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.
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.
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's planned enrollment of 64 is close to the median of 63 across 74 observational studies indexed under Malocclusion.
Browse Malocclusion studies →Andrea Scribante is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients referred for orthodontic evaluation at the Unit of Orthodontics and Paediatric Dentistry, Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, presenting skeletal malocclusion and undergoing routine orthodontic diagnostic assessment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Thoracic kyphotic angle
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.
Time frame: Baseline
Lumbar lordosis angle
The lumbar lordosis angle will be measured using the Spine 3D system and expressed in degrees.
Time frame: Baseline
Cervical curvature
Cervical curvature will be assessed using the Spine 3D system as part of the three-dimensional postural evaluation.
Time frame: Baseline
Trunk inclination
Trunk inclination will be measured using the Spine 3D system and expressed as a quantitative postural parameter.
Time frame: Baseline
Pelvic rotation
Pelvic rotation will be assessed using the Spine 3D system and recorded as a quantitative postural parameter.
Time frame: Baseline
Lateral spinal deviations
Lateral spinal deviations will be evaluated using the Spine 3D system to assess frontal plane postural asymmetries.
Time frame: Baseline
Scapular symmetry
Scapular symmetry will be assessed using the Spine 3D system as part of the postural analysis.
Time frame: Baseline
Pelvic symmetry
Pelvic symmetry will be assessed using the Spine 3D system as part of the postural analysis.
Time frame: Baseline
Sella-Nasion-A Point angle
The Sella-Nasion-A Point angle will be calculated using the lateral cephalometric radiograph to assess the anteroposterior position of the maxilla.
Time frame: Baseline
Sella-Nasion-B Point angle
The Sella-Nasion-B Point angle will be calculated using the lateral cephalometric radiograph to assess the anteroposterior position of the mandible.
Time frame: Baseline
A Point-Nasion-B Point angle
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.
Time frame: Baseline
Temporomandibular disorders
Presence and severity of temporomandibular disorders will be assessed using the Helkimo index.
Time frame: Baseline
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Andrea Scribante