NCT06891859

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
Last Updated

March 25, 2025

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

March 18, 2025

Last Update Submit

March 22, 2025

Conditions

Keywords

head posturemasseterbody balancetemporomandibular joint

Outcome Measures

Primary Outcomes (9)

  • 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.

    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.

    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.

    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.

    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.

    February 2024 and June 2024

  • Maximum pain-free mouth opening

    The maximum pain-free mouth opening was recorded using a 10 cm ruler.

    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.

    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).

    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.

    February 2024 and June 2024

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

University students

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandirma Onyedi Eylul University

Balıkesir, Turkey, 10200, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Assistant

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 24, 2025

Study Start

April 19, 2024

Primary Completion

June 28, 2024

Study Completion

December 23, 2024

Last Updated

March 25, 2025

Record last verified: 2024-08

Locations