An observational study in Postural; Defect, Stomatognathic System Abnormalities and Malocclusion, sponsored by University of Rzeszow. Status unknown at 1 site in Poland. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-03-23.
Sponsored by University of Rzeszow · Observational
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.
Both disorders of the stomatognathic system and body posture defects concern an increasingly younger population in Poland and in the world. The scale of both problems is constantly increasing. Structural and functional disorders in the area of the stomatognathic system have begun to be known as a disease of modern civilization. Bite defects immediately after tooth decay are the second most common dental problem for children around the world. The scale of the problem according to some sources makes up 75% of this population. Similarly, in the case of body posture defects in the spine, lower limbs and feet, it is estimated that they are present in up to 60-70% of Polish children. The critical period for the development of defects in both posture and the orofacial area falls at the same age, i.e. early school and puberty. Despite of the extensive literature describing both issues, there is still no clear and objective scientific evidence that would confirm the correlation of the two phenomena.
The presented project is an original cross-sectional study. 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.
The subjects will be divided into subgroups: a) children with correct body posture and without stomatognathic system dysfunction; b) children with a diagnosis of body posture defect; c) children with a diagnosis of malocclusion; d) children with a stomatognathic system dysfunction. After obtaining the mandatory written consent of the parent and child, the child's medical qualification to participate in the study will include the exclusion of: 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. The inclusion criterion will include: age of study participant from 6 to 15 years of age, in case of an existing defect in body posture/or malocclusion/or dysfunction of the stomatoghnatic system, lack of specific causes.
Methods
457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.
This study's planned enrollment of 400 is above the median of 61 across 78 observational studies indexed under Malocclusion.
Browse Malocclusion studies →University of Rzeszow is the lead sponsor of 37 studies on the registry; 14 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at baseline, immediately after medical qualification to the study
Functional assessment of the spine and lower limbs
The assessment with the use of 3D device which is intertial sensor of movement. Its application in the scientific sphere allows the goniometric evaluation (range of movement) of the articulations. In the study it allows to assess the functional head and neck mobility and additionally in lumbar spine and lower limbs joints
Time frame: at baseline, immediately after medical qualification to the study
Anthropometric measurements
Seca 213 stadiometer - equipment necessary to examine the basic anthropometric measurements of height and weight. Waist and hip circumference will be measured by centimetre tape.
Time frame: at baseline, immediately after medical qualification to the study
Body mass composition analysis
Tanita MC 780 MA- segment body mass composition analyser using the bioimpedance method (BIA). The equipment has 8 electrodes for a detailed analysis with segment reading - the division of fat and muscle mass in the left and right arm, left and right leg and body, as well as between the leg muscularity index, segment index for fat tissue and muscle mass.
Time frame: at baseline, immediately after medical qualification to the study
Foot pressure
FreeMed Posture MAXI60 Pedobarograph will allow to access pressure fields acting between the plantar surface of the foot and a supporting surface. The device shows exactly degree of patient's foot presses on the ground. Additionally, it will allow testing the patient's equivalent responses.
Time frame: at baseline, immediately after medical qualification to the study
Body balance
FreeMed Posture MAXI60 Pedobarograph will allow to access pressure fields acting between the plantar surface of the foot and a supporting surface. The device shows exactly degree of patient's foot presses on the ground. Additionally, it will allow testing the patient's equivalent responses.
Time frame: at baseline, immediately after medical qualification to the study
7-day physical activity
ActiGraph GT3X-BT accelerometers are currently the most accurate and objective motion sensors for assessing physical activity. The devices detect the acceleration of body movement in three planes, giving the possibility of reliable measurement of the intensity and duration of physical activity, as well as the number of steps performed and the time spent passively. Motion parameters are read thanks to a piezoelectric sensor. The subject will wear an accelerometer on his waist for an uninterrupted period of 7 days, excluding bathing time and swimming lessons.
Time frame: at baseline, immediately after medical qualification to the study
Blood pressure
Medel Connect Cardio MB 10 blood pressure monitor for measuring systolic and diastolic blood pressure, heartbeat values, and ECG. Each subject will have their blood pressure tested three times.
Time frame: at baseline, immediately after medical qualification to the study
Plan to share: No
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University of Rzeszow