NCT07664059

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
25mo left

Started Sep 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

2.1 years

First QC Date

May 19, 2026

Last Update Submit

June 17, 2026

Conditions

MalocclusionTemporomandibular DisorderPostural; Defect

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (11)

  • Lumbar lordosis angle

    Baseline

  • Cervical curvature

    Baseline

  • Trunk inclination

    Baseline

  • Pelvic rotation

    Baseline

  • Lateral spinal deviations

    Baseline

  • +6 more secondary outcomes

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MalocclusionTemporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular Diseases

Central Study Contacts

Maria Gloria Nardi, Dr.

CONTACT

3386526714mariagloria.nardi01@universitadipavia.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 19, 2026

First Posted

June 23, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share