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Completed

NCT Number: NCT06891859

Temporomandibular Disorders and Balance Performance

This study aims to investigate the relationship of the temporomandibular joint with head posture, pressure pain threshold, and body balance.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bandirma Onyedi Eylul University

Balıkesir, Turkey, 10200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be a student at Bandırma Onyedi Eylül University
  • Must be willing to participate in the study
  • Aged between 18-30

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. 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.

Sponsors and collaborators

Lead sponsor

Bandırma Onyedi Eylül University

Other

Registry information

Official study title

Investigation of the Relationship Between Static and Dynamic Balance Performance and Temporomandibular Dysfunction Symptoms in Healthy Adults

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 24, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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