Stomatognathic SystemNCT05411770
The Relationship Between The Stomatognathic System, Spine Posture And Pelvic Symmetry
An observational study of Stomatognathic System and Spine, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to examine the relationship between the stomatognathic system, spine posture and pelvis symmetry. 91 healthy adolescence were included in the study. For stomatognathic system, temporomandibular range of motion with millimeter ruler, cervical joint range of motion and craniovertebral angle… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Stomatognathic System, Spine, Pelvis
- What is being tested?
- Thoracic kyphosis and lumbar lordosis angle assessment, Temporomandibular range of motion and Measuring the cervical joint range of motion
- Type of treatment
- Medical device
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2020to 30 Jul 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 10 to 18 years
- All sexes
- Child, Adult
Study population: Healthy adolescent individuals aged 10-18 years were included in the study.
Who may be able to join
- No known neurological, rheumatological, musculoskeletal problems
- Has no visual or hearing impairment
- Ability to adapt to the parameters to be applied in the study
- Ability to perform tests to be applied
- Consists of voluntary adolescent individuals whose families gave permission to participate in the study.
Who cannot join
- Receiving joint sounds in the form of clicks or crepitations from the TMJ during mouth opening and closing or chewing
- Passion and tenderness in the TMJ on palpation
- Having a tumor Having received orthodontic treatment in the last 3 years
- Having a history of head, neck and maxillofacial surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of The Relationship Between The Stomatognathic System, Spine Posture and Pelvic Symmetry in Adolescence Individuals
This study was planned to examine the relationship between the stomatognathic system, spine posture and pelvis symmetry. 91 healthy adolescence were included in the study. For stomatognathic system, temporomandibular range of motion with millimeter ruler, cervical joint range of motion and craniovertebral angle measurement with goniometer, tragus-wall distance measurement with tape measure, kyphosis and lordosis angle measurement with Baseline Bubble Inclinometer®, trunk rotation angle scoliometer for scoliosis, lower extremity length measurements for pelvis symmetry were made using a tape measure.
- Conditions
- Stomatognathic System, Spine, Pelvis, Posture
- Being tested
- Thoracic kyphosis and lumbar lordosis angle assessment, Temporomandibular range of motion, Measuring the cervical joint range of motion, Craniovertebral angle measurement, Tragus-to-wall distance measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic kyphosis and lumbar lordosis angle assessmentDevice
Thoracic kyphosis and lumbar lordosis angle assessment was performed with the reliable Baseline Bubble Inclinometer®.
Temporomandibular range of motionDevice
TMJ range of motion, maximum mouth opening amount (MAAM), right and left lateral movements of the mandible (laterotrusion), anterior movement of the mandible (protrusion), and backward movement of the mandible (retrusion) were measured with a millimetric ruler, while the adolescent was seated on a chair.
Measuring the cervical joint range of motionDevice
Cervical joint flexion, extension, lateral flexion and rotation ranges of motion were measured with a universal goniometer while the adolescent was sitting in a chair.
Craniovertebral angle measurementDevice
Head posture of the adolescent was evaluated by craniovertebral angle (CVA) method. Adolescents sat on a chair with back support in an upright position and turned sideways to the worker. The pivot point was accepted as the seventh cervical vertebra, and the angle between the head (tragus) and the horizontal plane was measured with a goniometer and recorded in degrees.
Tragus-to-wall distance measurementDevice
Tragus-to-wall distance was measured using a tape measure and recorded in cm.
Scoliosis angle assessmentDevice
Scoliosis angle assessment was done with a scoliometer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracic kyphosis and lumbar lordosis angle assessment
Thoracic kyphosis and lumbar lordosis angle assessment was performed with the reliable Baseline Bubble Inclinometer®.
Measured: 12 Weeks
Temporomandibular range of motion
TMJ range of motion, maximum mouth opening amount (MAAM), right and left lateral movements of the mandible (laterotrusion), anterior movement of the mandible (protrusion), and backward movement of the mandible (retrusion) were measured with a millimetric ruler, while the adolescent was seated on a chair and recorded in mm.
Measured: 12 Weeks
Measuring the cervical joint range of motion
Cervical joint flexion, extension, lateral flexion and rotation ranges of motion were measured with a universal goniometer while the adolescent was sitting in a chair.
Measured: 12 Weeks
Craniovertebral angle measurement
Head posture of the adolescent was evaluated by craniovertebral angle (CVA) method. Adolescents sat on a chair with back support in an upright position and turned sideways to the worker. The pivot point was accepted as the seventh cervical vertebra, and the angle between the head (tragus) and the horizontal plane was measured with a goniometer and recorded in degrees.
Measured: 12 Weeks
Tragus-to-wall distance measurement
Tragus-to-wall distance was measured using a tape measure and recorded in cm.
Measured: 12 Weeks
Scoliosis angle assessment
Scoliosis angle assessment was done with a scoliometer.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start30 Jul 2020
- Primary completion30 Mar 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomatognathic SystemStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emine Betül Demirkapi, MSc, Principal investigator, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411770
- Sponsor's protocol ID
- 2020/09
- Status last verified
- May 2022
- First submitted
- 31 May 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of The Relationship Between The Stomatognathic System, Spine Posture and Pelvic Symmetry in Adolescence Individuals
- ClinicalTrials.gov ID
- NCT05411770
- Acronym / sponsor ID
- 2020/09
- Conditions
- Stomatognathic System, Spine, Pelvis, Posture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 9 Jun 2022 (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.
This study was planned to examine the relationship between the stomatognathic system, spine posture and pelvis symmetry. 91 healthy adolescence were included in the study. For stomatognathic system, temporomandibular range of motion with millimeter ruler, cervical joint range of motion and craniovertebral angle measurement with goniometer, tragus-wall distance measurement with tape measure, kyphosis and lordosis angle measurement with Baseline Bubble Inclinometer®, trunk rotation angle scoliometer for scoliosis, lower extremity length measurements for pelvis symmetry were made using a tape measure.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Healthy adolescent individuals aged 10-18 years were included in the study.
Key inclusion criteria (5 listed)
- No known neurological, rheumatological, musculoskeletal problems
- Has no visual or hearing impairment
- Ability to adapt to the parameters to be applied in the study
- Ability to perform tests to be applied
- Consists of voluntary adolescent individuals whose families gave permission to participate in the study.
Key exclusion criteria (4 listed)
- Receiving joint sounds in the form of clicks or crepitations from the TMJ during mouth opening and closing or chewing
- Passion and tenderness in the TMJ on palpation
- Having a tumor Having received orthodontic treatment in the last 3 years
- Having a history of head, neck and maxillofacial surgery
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 |
|---|---|---|
| Thoracic kyphosis and lumbar lordosis angle assessmentThoracic kyphosis and lumbar lordosis angle assessment was performed with the reliable Baseline Bubble Inclinometer®. | Device | – |
| Temporomandibular range of motionTMJ range of motion, maximum mouth opening amount (MAAM), right and left lateral movements of the mandible (laterotrusion), anterior movement of the mandible (protrusion), and backward movement of the mandible (retrusion) were measured with a millimetric ruler, while the adolescent was seated on a chair. | Device | – |
| Measuring the cervical joint range of motionCervical joint flexion, extension, lateral flexion and rotation ranges of motion were measured with a universal goniometer while the adolescent was sitting in a chair. | Device | – |
| Craniovertebral angle measurementHead posture of the adolescent was evaluated by craniovertebral angle (CVA) method. Adolescents sat on a chair with back support in an upright position and turned sideways to the worker. The pivot point was accepted as the seventh cervical vertebra, and the angle between the head (tragus) and the horizontal plane was measured with a goniometer and recorded in degrees. | Device | – |
| Tragus-to-wall distance measurementTragus-to-wall distance was measured using a tape measure and recorded in cm. | Device | – |
| Scoliosis angle assessmentScoliosis angle assessment was done with a scoliometer. | Device | – |
Primary outcome
Thoracic kyphosis and lumbar lordosis angle assessment
Time frame: 12 Weeks
Thoracic kyphosis and lumbar lordosis angle assessment was performed with the reliable Baseline Bubble Inclinometer®.
Temporomandibular range of motion
Time frame: 12 Weeks
TMJ range of motion, maximum mouth opening amount (MAAM), right and left lateral movements of the mandible (laterotrusion), anterior movement of the mandible (protrusion), and backward movement of the mandible (retrusion) were measured with a millimetric ruler, while the adolescent was seated on a chair and recorded in mm.
Measuring the cervical joint range of motion
Time frame: 12 Weeks
Cervical joint flexion, extension, lateral flexion and rotation ranges of motion were measured with a universal goniometer while the adolescent was sitting in a chair.
Craniovertebral angle measurement
Time frame: 12 Weeks
Head posture of the adolescent was evaluated by craniovertebral angle (CVA) method. Adolescents sat on a chair with back support in an upright position and turned sideways to the worker. The pivot point was accepted as the seventh cervical vertebra, and the angle between the head (tragus) and the horizontal plane was measured with a goniometer and recorded in degrees.
Tragus-to-wall distance measurement
Time frame: 12 Weeks
Tragus-to-wall distance was measured using a tape measure and recorded in cm.
Scoliosis angle assessment
Time frame: 12 Weeks
Scoliosis angle assessment was done with a scoliometer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No
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.
Emine Betül Demirkapi, MSc principal investigator
Sanko University
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 Stomatognathic System and Spine, run by Sanko University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 9 Jun 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Thoracic kyphosis and lumbar lordosis angle assessment (time frame: 12 Weeks). The study lists 6 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 9 Jun 2022.