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Набор скоро начнётся NCT07664059

Postural Assessment in Patients With Malocclusions

Наблюдательное Malocclusion Temporomandibular Disorder Postural; Defect

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Lateral teleradiography, Temporomandibular assessment with Helkimo Index, Three-dimensional postural assessment.
Кому может быть актуально
Состояния в реестре: Malocclusion, Temporomandibular Disorder, Postural; Defect. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Postural Assessment Using 3D Spine Analysis in Patients With Malocclusions

Обзор

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.

Подробное описание

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.

Вмешательства

  • Лучевая терапия Lateral 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.
  • Другое Temporomandibular 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.
  • Другое Three-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.

Первичные конечные точки

  • Thoracic kyphotic angle [Срок оценки: Baseline]
Вторичные конечные точки (11)
  • Lumbar lordosis angle [Срок оценки: Baseline]
  • Cervical curvature [Срок оценки: Baseline]
  • Trunk inclination [Срок оценки: Baseline]
  • Pelvic rotation [Срок оценки: Baseline]
  • Lateral spinal deviations [Срок оценки: Baseline]
  • Scapular symmetry [Срок оценки: Baseline]
  • Pelvic symmetry [Срок оценки: Baseline]
  • Sella-Nasion-A Point angle [Срок оценки: Baseline]
  • Sella-Nasion-B Point angle [Срок оценки: Baseline]
  • A Point-Nasion-B Point angle [Срок оценки: Baseline]
  • Temporomandibular disorders [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07664059 · 2026-POSTUREOCCLUSION

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗