MalocclusionNCT07664059
Postural Assessment in Patients With Malocclusions
An observational study of Malocclusion and Temporomandibular Disorder, run by Andrea Scribante.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Temporomandibular Disorder, Postural; Defect
- What is being tested?
- Lateral teleradiography, Temporomandibular assessment with Helkimo Index and Three-dimensional postural assessment
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Sep 2028
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Use of medications affecting musculoskeletal function
- Inability to undergo postural assessment
- Lack of written informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Postural Assessment Using 3D Spine Analysis in Patients With Malocclusions
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.
Read the 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.
- Conditions
- Malocclusion, Temporomandibular Disorder, Postural; Defect
- Being tested
- Lateral teleradiography, Temporomandibular assessment with Helkimo Index, Three-dimensional postural assessment
- Medical subject headings
- Malocclusion, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral teleradiographyRadiation
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.
Temporomandibular assessment with Helkimo IndexOther
The presence and severity of temporomandibular disorders will also be evaluated using the Helkimo index as part of the routine orthodontic diagnostic assessment.
Three-dimensional postural assessmentOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (11)
Lumbar lordosis angle
The lumbar lordosis angle will be measured using the Spine 3D system and expressed in degrees.
Measured: Baseline
Cervical curvature
Cervical curvature will be assessed using the Spine 3D system as part of the three-dimensional postural evaluation.
Measured: Baseline
Trunk inclination
Trunk inclination will be measured using the Spine 3D system and expressed as a quantitative postural parameter.
Measured: Baseline
Pelvic rotation
Pelvic rotation will be assessed using the Spine 3D system and recorded as a quantitative postural parameter.
Measured: Baseline
Lateral spinal deviations
Lateral spinal deviations will be evaluated using the Spine 3D system to assess frontal plane postural asymmetries.
Measured: Baseline
Scapular symmetry
Scapular symmetry will be assessed using the Spine 3D system as part of the postural analysis.
Measured: Baseline
Pelvic symmetry
Pelvic symmetry will be assessed using the Spine 3D system as part of the postural analysis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Temporomandibular disorders
Presence and severity of temporomandibular disorders will be assessed using the Helkimo index.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrea Scribante
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrea Scribante, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664059
- Sponsor's protocol ID
- 2026-POSTUREOCCLUSION
- Status last verified
- Jun 2026
- First submitted
- 19 May 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Assessment Using 3D Spine Analysis in Patients With Malocclusions
- ClinicalTrials.gov ID
- NCT07664059
- Acronym / sponsor ID
- 2026-POSTUREOCCLUSION
- Conditions
- Malocclusion, Temporomandibular Disorder, Postural; Defect
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Andrea ScribanteUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 23 Jun 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Previous orthodontic treatment
- Previous orthopaedic treatment affecting posture
- Presence of craniofacial syndromes or congenital anomalies
- History of spinal surgery
- Significant musculoskeletal disorders
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 |
|---|---|---|
| Lateral teleradiographyOrthodontic 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. | Radiation | – |
| Temporomandibular assessment with Helkimo IndexThe presence and severity of temporomandibular disorders will also be evaluated using the Helkimo index as part of the routine orthodontic diagnostic assessment. | Other | – |
| Three-dimensional postural assessmentAll 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. | Other | – |
Primary outcome
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.
11 secondary outcomes
Lumbar lordosis angle
Time frame: Baseline
Cervical curvature
Time frame: Baseline
Trunk inclination
Time frame: Baseline
Pelvic rotation
Time frame: Baseline
Lateral spinal deviations
Time frame: Baseline
Scapular symmetry
Time frame: Baseline
Pelvic symmetry
Time frame: Baseline
Sella-Nasion-A Point angle
Time frame: Baseline
Sella-Nasion-B Point angle
Time frame: Baseline
A Point-Nasion-B Point angle
Time frame: Baseline
Temporomandibular disorders
Time frame: Baseline
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 23 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion and Temporomandibular Disorder, run by Andrea Scribante.
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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Maria Gloria Nardi, Dr. (3386526714, mariagloria.nardi01@universitadipavia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracic kyphotic angle (time frame: Baseline). 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 23 Jun 2026.