NCT04317131

Brief Summary

The aim of the study is to demonstrate a correlation between body posture and the structure and function of the stomatognathic system in school-age children.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 9, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2021

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

1 month

First QC Date

December 9, 2019

Last Update Submit

March 17, 2020

Conditions

Keywords

body posturestomatognathic systemmalocclusionchildren

Outcome Measures

Primary Outcomes (4)

  • Clinical examination of the stomatognathic system (structural)

    Assessment of occlusion by visual method according to Angle classification. Research Diagnostic Criteria of Functional Disorders of the Masticatory System.

    at baseline, immediately after medical qualification to the study

  • Comprehensive body posture assessment

    Static and dynamic body posture test using 4th Generation MORA which enables a detailed and spatial analysis of body posture by photogrammetric.

    at baseline, immediately after medical qualification to the study

  • Clinical examination of the stomatognathic system (functional)

    JMA+ Analyser (Jaw Motion Analyzer) system will allow to analyse movement and function of the temporomandibular joints, mandibular position, condyle position (EPA), and access the muscle action potentials through bipolar skin surface electrodes EMG.

    at baseline, immediately after medical qualification to the study

  • Comprehensive body posture assessment

    Next device used to to the body posture assessment will be KINEOD with pedobarograph which is a modern device for 3D analysis of body posture, in particular the back, but also lower limbs. The KINEOD system uses image acquisition technology with the aid of infrared. Therefore, it is a perfect complement to examining body posture using the so-called photogrammetric method, so-called moire projection method.

    at baseline, immediately after medical qualification to the study

Secondary Outcomes (7)

  • Functional assessment of the spine and lower limbs

    at baseline, immediately after medical qualification to the study

  • Anthropometric measurements

    at baseline, immediately after medical qualification to the study

  • Body mass composition analysis

    at baseline, immediately after medical qualification to the study

  • Foot pressure

    at baseline, immediately after medical qualification to the study

  • Body balance

    at baseline, immediately after medical qualification to the study

  • +2 more secondary outcomes

Interventions

Interview and clinical examination of stomatognathic system based on standardized tool BDK/ZCURNŻ.

Examination with the use of JMA+Analyser (Jaw Motion Analyser) to analyse movement and function of the temporomandibular joints, mandibular position, condyle position (EPA), and access the muscle action potentials through bipolar skin surface electrodes EMG, assessment of occlusion by visual method according to Angle Classification.

Comprehensive, three- dimensional examination of the body posture (static and dynamic) in the area of the spine, lower limbs and feet, performed by photogrammetric method (4th Generation MORA) and non- invasive image acquisition technology with the aid of infrared (Kineod) and The CQElektronik system.

Functional assessment of the spine and lower limbs mobility trough a wireless motion sensor Moover.

Anthropometric measurements (height, weight, waist and hip circumference, skin folds), foot pressure on the ground and body balance accessed by pedobarograph FreeMed, body mass components measured by the Tanita MC 980 MA (BIA method), evaluation of 7-days of physical activity by accelerometer ActiGraph GT3X-BT, blood pressure measurement by Medel Connect Cardio MB 10 monitor.

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

A 400 school-age children between 6 and 15 years of age will participate in the study. Research will be conducted in randomly selected orthodontic clinics and primary schools.

You may qualify if:

  • age of study participant from 6 to 15 years of age
  • in case of an existing defect in body posture, lack of specific causes
  • in case of an existing malocclusion, lack of specific causes
  • in case of dysfunction of the stomatognathic system, lack of specific causes

You may not qualify if:

  • congenital structural defects of the spine,
  • chronic diseases of the nervous system,
  • genetic diseases,
  • neuromuscular dystrophy,
  • endocrine disorder
  • an ongoing contagious disease
  • present locomotor fracture
  • current muscular injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rzeszów

Rzeszów, 35-205, Poland

Location

MeSH Terms

Conditions

Stomatognathic System AbnormalitiesMalocclusion

Condition Hierarchy (Ancestors)

Stomatognathic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesTooth Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 9, 2019

First Posted

March 23, 2020

Study Start

June 30, 2020

Primary Completion

July 30, 2020

Study Completion

January 5, 2021

Last Updated

March 23, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations