University StudentsNCT06891859
Temporomandibular Disorders and Balance Performance
An observational study of University Students, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the relationship of the temporomandibular joint with head posture, pressure pain threshold, and body balance. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- University Students
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Apr 2024to 23 Dec 2024
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: University students
Who may be able to join
- Must be a student at Bandırma Onyedi Eylül University
- Must be willing to participate in the study
- Aged between 18-30
Who cannot join
- Individuals who have undergone masseter botox treatment
- Individuals diagnosed with temporomandibular joint disorders and/or bruxism
- Individuals with musculoskeletal problems showing evidence of specific pathological conditions, such as fractures or rheumatoid diseases related to the lower extremities, spine, and/or temporomandibular joint
- Individuals who have undergone any surgery related to the lower extremities, spine, and/or temporomandibular joint
- Individuals who have received physical therapy related to the lower extremities, spine, and/or temporomandibular joint within the last six months
- Individuals diagnosed with psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bandirma Onyedi Eylul University
Balıkesir, Turkey, 10200
About this study
Official title: Investigation of the Relationship Between Static and Dynamic Balance Performance and Temporomandibular Dysfunction Symptoms in Healthy Adults
This study aims to investigate the relationship of the temporomandibular joint with head posture, pressure pain threshold, and body balance.
Read the detailed description
This cross-sectional study was conducted on university students aged 18-30 between April 2024 and December 2024. In the evaluation of the students, the Fonseca Anamnestic Questionnaire was used for temporomandibular joint dysfunction, the Research Diagnostic Criteria for Temporomandibular Disorders Examination Form was used for maximum pain-free mouth opening, presence of sound in temporomandibular joint movements, and palpation parameters of the temporomandibular joint and surrounding muscles. An algometer device was used for pressure pain threshold measurement, a goniometer for head-neck posture, EMG for measuring the activation of the masseter muscle, and the Korebalance Premier-19 device for static and dynamic body balance measurement.
- Conditions
- University Students
- Keywords
- head posture, masseter, body balance, temporomandibular joint
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic Data Form
Through this form, fundamental information such as the participants' age, height, body weight, sex, educational status, occupation, and marital status was recorded, along with their medical history, current medication use, past surgical interventions, and whether any treatment or intervention related to the temporomandibular joint (TMJ) had been performed within the last six months.
Measured: February 2024 and June 2024
Pressure pain threshold
Pressure pain threshold The pressure pain threshold measurement was conducted on the masseter muscles using an algometer.
Measured: February 2024 and June 2024
Numerical Pain Scale (NPS) Assessment
This scale ranges from 0 to 10, where patients indicate their pain level by selecting a number within the range of "0 - no pain" to "10 - worst possible pain" to describe the intensity of their experienced pain.
Measured: February 2024 and June 2024
Forward head posture
It was evaluated using the craniovertebral angle (CVA) method. The craniovertebral angle is defined as the angle formed between the horizontal line and the line connecting the tragus of the ear to the spinous process of the seventh cervical vertebra.
Measured: February 2024 and June 2024
Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
This form consists of criteria used for the diagnosis of commonly encountered temporomandibular disorders (TMD). Based on the results of the form, participants can be diagnosed with one or more conditions such as myofascial pain, osteoarthritis, arthralgia, disc displacement, and arthritis.
DC/TMD consists of two main sections. The first section includes criteria for diagnosing disorders related to the masticatory muscles and the temporomandibular joint (TMJ). The second section allows for a comprehensive assessment of pain and the individual's psychosocial status by evaluating factors such as pain intensity, pain-related disabilities, depression, and somatization.
Measured: February 2024 and June 2024
Maximum pain-free mouth opening
The maximum pain-free mouth opening was recorded using a 10 cm ruler.
Measured: February 2024 and June 2024
Fonseca's Anamnestic Questionnaire
Fonseca's Anamnestic Questionnaire (FAQ) was used for TMJ dysfunction. The FAQ has a multi-factor evaluation structure. The questionnaire consists of ten questions about pain in TMJ, head, and joints, with answer options of "No, Sometimes and Yes." A score of 25 and above was accepted as the presence of TMD.
Measured: February 2024- June 2024
Muscle Activation Assessment
In our study, a four-channel Neurotrac MyoPlus Pro 4 surface EMG biofeedback device was used to assess muscle activation. Participants sat in an upright position with standardized posture, and EMG signals were recorded from the bilateral masseter muscles using self-adhesive electrodes. EMG signals were recorded using self-adhesive electrodes measuring 2.5 cm × 2.5 cm. The electrodes were placed bilaterally on the masseter muscles, with an inter-electrode distance of 10 mm. Before normalization, maximum voluntary isometric contraction (MVIC) levels were recorded. Participants performed three five-second maximal clenching trials with one-minute rest intervals. After the MVIC measurement, bilateral masseter muscle activation was recorded again via EMG during balance assessments. Muscle activation during the task was analyzed using Neurotrac PC Software, and the results were reported as mean microvolt values and normalized data (%MVC).
Measured: February 2024 and June 2024
Static and Dynamic Balance Assessment
The Korebalance Premier-19 device was used to measure postural imbalances through anterior-posterior and medial-lateral sway. Postural deviations were assessed using a total score, where higher scores indicated poorer balance.
Static balance was tested with both eyes open and closed, with the device inflated to 6.0 PSI. Participants were instructed to maintain a stable posture and keep the "+" sign centered on the monitor. In the eyes-closed test, they adjusted their balance and position before the measurement began, followed by a five-second countdown, after which they attempted to maintain the same balance and position.
Dynamic balance was assessed only with eyes open, with the device inflated to 5.0 PSI. Participants tracked a moving target without external support. Each balance assessment lasted 30 seconds per participant.
Measured: February 2024 and June 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start19 Apr 2024
- Primary completion28 Jun 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for University StudentsStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mert Durukan, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891859
- Sponsor's protocol ID
- 2024 -31
- Status last verified
- Aug 2024
- First submitted
- 18 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Static and Dynamic Balance Performance and Temporomandibular Dysfunction Symptoms in Healthy Adults
- ClinicalTrials.gov ID
- NCT06891859
- Acronym / sponsor ID
- 2024 -31
- Conditions
- University Students
- Keywords
- head posture, masseter, body balance, temporomandibular joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 24 Mar 2025 (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 aims to investigate the relationship of the temporomandibular joint with head posture, pressure pain threshold, and body balance.
Detailed description
This cross-sectional study was conducted on university students aged 18-30 between April 2024 and December 2024. In the evaluation of the students, the Fonseca Anamnestic Questionnaire was used for temporomandibular joint dysfunction, the Research Diagnostic Criteria for Temporomandibular Disorders Examination Form was used for maximum pain-free mouth opening, presence of sound in temporomandibular joint movements, and palpation parameters of the temporomandibular joint and surrounding muscles. An algometer device was used for pressure pain threshold measurement, a goniometer for head-neck posture, EMG for measuring the activation of the masseter muscle, and the Korebalance Premier-19 device for static and dynamic body balance measurement.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- University students
Key inclusion criteria (3 listed)
- Must be a student at Bandırma Onyedi Eylül University
- Must be willing to participate in the study
- Aged between 18-30
Key exclusion criteria (6 listed)
- Individuals who have undergone masseter botox treatment
- Individuals diagnosed with temporomandibular joint disorders and/or bruxism
- Individuals with musculoskeletal problems showing evidence of specific pathological conditions, such as fractures or rheumatoid diseases related to the lower extremities, spine, and/or temporomandibular joint
- Individuals who have undergone any surgery related to the lower extremities, spine, and/or temporomandibular joint
- Individuals who have received physical therapy related to the lower extremities, spine, and/or temporomandibular joint within the last six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sociodemographic Data Form
Time frame: February 2024 and June 2024
Through this form, fundamental information such as the participants' age, height, body weight, sex, educational status, occupation, and marital status was recorded, along with their medical history, current medication use, past surgical interventions, and whether any treatment or intervention related to the temporomandibular joint (TMJ) had been performed within the last six months.
Pressure pain threshold
Time frame: February 2024 and June 2024
Pressure pain threshold The pressure pain threshold measurement was conducted on the masseter muscles using an algometer.
Numerical Pain Scale (NPS) Assessment
Time frame: February 2024 and June 2024
This scale ranges from 0 to 10, where patients indicate their pain level by selecting a number within the range of "0 - no pain" to "10 - worst possible pain" to describe the intensity of their experienced pain.
Forward head posture
Time frame: February 2024 and June 2024
It was evaluated using the craniovertebral angle (CVA) method. The craniovertebral angle is defined as the angle formed between the horizontal line and the line connecting the tragus of the ear to the spinous process of the seventh cervical vertebra.
Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
Time frame: February 2024 and June 2024
This form consists of criteria used for the diagnosis of commonly encountered temporomandibular disorders (TMD). Based on the results of the form, participants can be diagnosed with one or more conditions such as myofascial pain, osteoarthritis, arthralgia, disc displacement, and arthritis. DC/TMD consists of two main sections. The first section includes criteria for diagnosing disorders related to the masticatory muscles and the temporomandibular joint (TMJ). The second section allows for a comprehensive assessment of pain and the individual's psychosocial status by evaluating factors such as pain intensity, pain-related disabilities, depression, and somatization.
Maximum pain-free mouth opening
Time frame: February 2024 and June 2024
The maximum pain-free mouth opening was recorded using a 10 cm ruler.
Fonseca's Anamnestic Questionnaire
Time frame: February 2024- June 2024
Fonseca's Anamnestic Questionnaire (FAQ) was used for TMJ dysfunction. The FAQ has a multi-factor evaluation structure. The questionnaire consists of ten questions about pain in TMJ, head, and joints, with answer options of "No, Sometimes and Yes." A score of 25 and above was accepted as the presence of TMD.
Muscle Activation Assessment
Time frame: February 2024 and June 2024
In our study, a four-channel Neurotrac MyoPlus Pro 4 surface EMG biofeedback device was used to assess muscle activation. Participants sat in an upright position with standardized posture, and EMG signals were recorded from the bilateral masseter muscles using self-adhesive electrodes. EMG signals were recorded using self-adhesive electrodes measuring 2.5 cm × 2.5 cm. The electrodes were placed bilaterally on the masseter muscles, with an inter-electrode distance of 10 mm. Before normalization, maximum voluntary isometric contraction (MVIC) levels were recorded. Participants performed three five-second maximal clenching trials with one-minute rest intervals. After the MVIC measurement, bilateral masseter muscle activation was recorded again via EMG during balance assessments. Muscle activation during the task was analyzed using Neurotrac PC Software, and the results were reported as mean microvolt values and normalized data (%MVC).
Static and Dynamic Balance Assessment
Time frame: February 2024 and June 2024
The Korebalance Premier-19 device was used to measure postural imbalances through anterior-posterior and medial-lateral sway. Postural deviations were assessed using a total score, where higher scores indicated poorer balance. Static balance was tested with both eyes open and closed, with the device inflated to 6.0 PSI. Participants were instructed to maintain a stable posture and keep the "+" sign centered on the monitor. In the eyes-closed test, they adjusted their balance and position before the measurement began, followed by a five-second countdown, after which they attempted to maintain the same balance and position. Dynamic balance was assessed only with eyes open, with the device inflated to 5.0 PSI. Participants tracked a moving target without external support. Each balance assessment lasted 30 seconds per participant.
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 25 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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 University Students, run by Bandırma Onyedi Eylül 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 3 inclusion and 6 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 25 Mar 2025. 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?
Sociodemographic Data Form (time frame: February 2024 and June 2024). The study lists 9 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 25 Mar 2025.