Postural; DefectNCT04317131
Body Posture and the Stomatognathic System of School-age Children
An observational study of Postural; Defect and Stomatognathic System Abnormalities, run by University of Rzeszow at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Postural; Defect, Stomatognathic System Abnormalities, Malocclusion
- What is being tested?
- Research Diagnostic Criteria of Functional Disorders of the Masticatory System BKD / ZCURNŻ - Polish version, Clinical examination of the stomatognathic system (structural and functional) and 3D examination of the body posture
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 sitePoland
- Study dates
- 30 Jun 2020to 5 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Interdependence of Body Posture and the Stomatognathic System of School-age Children in Structural and Functional Terms
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.
Read the detailed description
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
- interview based on standardized questionnaires, i.e. Research Diagnostic Criteria of Functional Disorders of the Masticatory System BKD / ZCURNŻ
- Polish version, TMD Questionnaire, Neck Disability Index, International Physical Activity Questionnaire (IPAQ) (short version), Questionnaire on Food Related Behavior (KZZJ)
- clinical examination of the stomatognathic system (structural and functional), using JMA+ Analyser (Jaw Motion Analyzer) 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 3D 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 CQ Elektronik system.
- functional assessment of the spine and lower limbs mobility trough a wireless motion sensor Moover.
- complementary tests, i.e. 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.
- Being tested
- Research Diagnostic Criteria of Functional Disorders of the Masticatory System BKD / ZCURNŻ - Polish version, Clinical examination of the stomatognathic system (structural and functional), 3D examination of the body posture, Functional assessment of the spine and lower limbs, Complementary tests
- Keywords
- body posture, stomatognathic system, malocclusion, children
- Medical subject headings
- Stomatognathic System Abnormalities, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research Diagnostic Criteria of Functional Disorders of the Masticatory System BKD / ZCURNŻ - Polish versionDiagnostic test
Interview and clinical examination of stomatognathic system based on standardized tool BDK/ZCURNŻ.
Clinical examination of the stomatognathic system (structural and functional)Device
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.
3D examination of the body postureDevice
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 limbsDevice
Functional assessment of the spine and lower limbs mobility trough a wireless motion sensor Moover.
Complementary testsDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at baseline, immediately after medical qualification to the study
Secondary outcomes (7)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at baseline, immediately after medical qualification to the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start30 Jun 2020 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion5 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural; DefectStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justyna Leszczak, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317131
- Sponsor's protocol ID
- BodyPostureTMD
- Status last verified
- Mar 2020
- First submitted
- 9 Dec 2019
- Last updated
- 23 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interdependence of Body Posture and the Stomatognathic System of School-age Children in Structural and Functional Terms
- ClinicalTrials.gov ID
- NCT04317131
- Acronym / sponsor ID
- BodyPostureTMD
- Keywords
- body posture, stomatognathic system, malocclusion, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 30 Jun 2020 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 5 Jan 2021 (estimated)
- First posted
- 23 Mar 2020 (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.
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.
Detailed description
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
- interview based on standardized questionnaires, i.e. Research Diagnostic Criteria of Functional Disorders of the Masticatory System BKD / ZCURNŻ
- Polish version, TMD Questionnaire, Neck Disability Index, International Physical Activity Questionnaire (IPAQ) (short version), Questionnaire on Food Related Behavior (KZZJ)
- clinical examination of the stomatognathic system (structural and functional), using JMA+ Analyser (Jaw Motion Analyzer) 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 3D 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 CQ Elektronik system.
- functional assessment of the spine and lower limbs mobility trough a wireless motion sensor Moover.
- complementary tests, i.e. 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- congenital structural defects of the spine,
- chronic diseases of the nervous system,
- genetic diseases,
- neuromuscular dystrophy,
- endocrine disorder
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 |
|---|---|---|
| Research Diagnostic Criteria of Functional Disorders of the Masticatory System BKD / ZCURNŻ - Polish versionInterview and clinical examination of stomatognathic system based on standardized tool BDK/ZCURNŻ. | Diagnostic test | – |
| Clinical examination of the stomatognathic system (structural and functional)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. | Device | – |
| 3D examination of the body postureComprehensive, 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. | Device | – |
| Functional assessment of the spine and lower limbsFunctional assessment of the spine and lower limbs mobility trough a wireless motion sensor Moover. | Device | – |
| Complementary testsAnthropometric 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. | Device | – |
Primary outcome
Clinical examination of the stomatognathic system (structural)
Time frame: at baseline, immediately after medical qualification to the study
Assessment of occlusion by visual method according to Angle classification. Research Diagnostic Criteria of Functional Disorders of the Masticatory System.
Comprehensive body posture assessment
Time frame: at baseline, immediately after medical qualification to the study
Static and dynamic body posture test using 4th Generation MORA which enables a detailed and spatial analysis of body posture by photogrammetric.
Clinical examination of the stomatognathic system (functional)
Time frame: at baseline, immediately after medical qualification to the study
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.
Comprehensive body posture assessment
Time frame: at baseline, immediately after medical qualification to the study
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.
7 secondary outcomes
Functional assessment of the spine and lower limbs
Time frame: at baseline, immediately after medical qualification to the study
Anthropometric measurements
Time frame: at baseline, immediately after medical qualification to the study
Body mass composition analysis
Time frame: at baseline, immediately after medical qualification to the study
Foot pressure
Time frame: at baseline, immediately after medical qualification to the study
Body balance
Time frame: at baseline, immediately after medical qualification to the study
7-day physical activity
Time frame: at baseline, immediately after medical qualification to the study
Blood pressure
Time frame: at baseline, immediately after medical qualification to the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postural; Defect and Stomatognathic System Abnormalities, run by University of Rzeszow at 1 site in Poland.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical examination of the stomatognathic system (structural) (time frame: at baseline, immediately after medical qualification to the study). The study lists 4 primary outcomes in all. 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 Mar 2020.