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Temporomandibular DisordersNCT07750743

Temporomandibular Disorders With and Without Chronic Neck Pain

An observational study of Temporomandibular Disorders, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Temporomandibular disorders (TMD) are common musculoskeletal conditions frequently accompanied by cervical dysfunction. Although previous studies have demonstrated associations between cervical impairments and temporomandibular symptoms, the influence of chronic neck pain on cervical function and its contribution to… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Temporomandibular Disorders
How many people
67 participants
Where
1 siteTurkey (Türkiye)
Study dates
23 Jun 2026to 15 Jul 2026
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adults aged 18-65 years diagnosed with temporomandibular disorders (TMD) according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) who were recruited from the Tunceli Oral and Dental Health Center. Participants were classified into two groups according to the presence or absence of chronic neck pain and underwent comprehensive assessments of temporomandibular and cervical function.

Who may be able to join

  • Adults aged 18 to 65 years.
  • Diagnosed with temporomandibular disorders (TMD) according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
  • Able and willing to provide written informed consent.

Who cannot join

  • Presence of cardiac, pulmonary, neurological, orthopedic, or other systemic diseases.
  • Current infection or malignancy.
  • History of cervical spine surgery.
  • Acute cervical trauma or fracture.
  • Cognitive, psychological, or mental conditions that could interfere with study assessments.
  • Inability or unwillingness to complete the study assessments.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Munzur University Faculty of Health Sciences

    Tunceli, Bolu

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Cervical Function in Individuals With Temporomandibular Disorders With and Without Chronic Neck Pain: Determinants of Temporomandibular Function

Temporomandibular disorders (TMD) are common musculoskeletal conditions frequently accompanied by cervical dysfunction. Although previous studies have demonstrated associations between cervical impairments and temporomandibular symptoms, the influence of chronic neck pain on cervical function and its contribution to temporomandibular outcomes remain incompletely understood.

This cross-sectional study aims to compare cervical and temporomandibular characteristics between individuals with TMD with chronic neck pain and those without chronic neck pain, and to identify cervical factors associated with temporomandibular function, maximal mouth opening, and temporomandibular pain. A total of 67 adults diagnosed with TMD according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) will be enrolled and allocated into two groups based on the presence or absence of chronic neck pain.

Read more

Participants will undergo comprehensive assessments including temporomandibular joint range of motion, maximal mouth opening, Jaw Functional Limitation Scale-20 (JFLS-20), craniovertebral angle, cervical range of motion, deep cervical flexor muscle endurance, cervical proprioception, Neck Disability Index (NDI), and pain intensity using the Visual Analog Scale (VAS). Group differences and the relationships between cervical function and temporomandibular outcomes will be examined using correlation and regression analyses.

The findings are expected to clarify the contribution of cervical posture, mobility, muscle endurance, and proprioception to temporomandibular dysfunction. The results may support the incorporation of comprehensive cervical assessment and cervical-focused rehabilitation strategies into the clinical management of individuals with temporomandibular disorders.

Read the detailed description

Temporomandibular disorders (TMD) are among the most prevalent musculoskeletal conditions affecting the temporomandibular joint, masticatory muscles, and associated structures. These disorders are characterized by pain, restricted mandibular movement, joint sounds, and impaired jaw function, resulting in limitations in daily activities and reduced quality of life. Increasing evidence suggests that TMD should not be considered an isolated disorder of the temporomandibular joint but rather a complex musculoskeletal condition involving close anatomical, biomechanical, and neurophysiological interactions with the cervical spine. The trigeminocervical complex provides a neurophysiological basis for this relationship by integrating afferent input from both the cervical spine and the trigeminal system, thereby influencing pain processing, motor control, and sensorimotor function.

Individuals with TMD frequently demonstrate forward head posture, reduced cervical range of motion, impaired deep cervical flexor muscle function, and altered cervical proprioception. Although previous studies have reported associations between cervical dysfunction and temporomandibular symptoms, most investigations have evaluated only isolated components of cervical function. Furthermore, the specific influence of chronic neck pain on cervical impairments and its contribution to temporomandibular function has not been comprehensively investigated. Therefore, a more integrated evaluation of cervical posture, mobility, muscle endurance, and proprioception is warranted to better understand the interaction between cervical dysfunction and TMD.

The primary objective of this cross-sectional study is to compare cervical function and temporomandibular characteristics between individuals with TMD accompanied by chronic neck pain and those with TMD without chronic neck pain. A secondary objective is to determine which cervical variables independently predict temporomandibular function, maximal mouth opening, and temporomandibular pain intensity.

A total of 67 adults diagnosed with TMD according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) will participate in the study. Participants will be recruited from the Tunceli Oral and Dental Health Center and divided into two groups according to the presence or absence of chronic neck pain. Individuals in the chronic neck pain group must have experienced neck pain for at least three months, report neck pain on the Visual Analog Scale (VAS), and have a Neck Disability Index (NDI) score of at least 5. Participants without chronic neck pain must report no neck pain during the previous three months, have a VAS score of zero, and an NDI score below 5. Eligible participants will be between 18 and 65 years of age and diagnosed with TMD according to the DC/TMD criteria. Individuals with cardiac, pulmonary, neurological, orthopedic, or other systemic diseases, infection, malignancy, previous cervical spine surgery, acute cervical trauma or fracture, or cognitive or psychological conditions that could interfere with the assessments will be excluded.

All participants will undergo standardized clinical assessments performed by trained investigators. Temporomandibular joint function will be evaluated by measuring maximal mouth opening, lateral excursion, and protrusion range of motion. Functional limitation related to TMD will be assessed using the Jaw Functional Limitation Scale-20 (JFLS-20). Cervical posture will be evaluated by measuring the craniovertebral angle using the PostureScreen application. Total cervical range of motion will be measured with a Cervical Range of Motion (CROM) device. Deep cervical flexor muscle endurance will be assessed using the Craniocervical Flexion Test. Cervical proprioception will be evaluated using the Joint Position Error Test. Neck disability will be assessed using the Neck Disability Index (NDI), while temporomandibular joint pain intensity and neck pain intensity will be measured using the Visual Analog Scale (VAS).

Statistical analyses will include comparisons between groups using independent-samples t-tests. Associations between cervical and temporomandibular variables will be examined using Pearson correlation analyses. Multiple linear regression and hierarchical regression analyses will be performed to identify independent cervical predictors of temporomandibular function, maximal mouth opening, and temporomandibular pain intensity. Statistical significance will be defined as a two-sided p-value of less than 0.05.

This study is expected to improve the understanding of the relationship between cervical dysfunction and temporomandibular disorders by comprehensively evaluating multiple components of cervical function within the same population. The findings may provide clinically relevant evidence supporting comprehensive cervical assessment and the integration of cervical-focused rehabilitation strategies into the management of individuals with temporomandibular disorders.

Keywords
Temporomandibular disorders, chronic neck pain, cervical proprioception, deep cervical flexor muscles, craniovertebral angle
Medical subject headings
Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07750743
Study groupRoleWhat they receive
TMD with Chronic Neck PainAdults diagnosed with temporomandibular disorders (TMD) according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) who had chronic neck pain for at least 3 months, a Visual Analog Scale (VAS) score greater than 0, and a Neck Disability Index (NDI) score of ≥5. Participants underwent assessments of temporomandibular function, cervical posture, cervical range of motion, deep cervical flexor endurance, cervical proprioception, neck disability, and pain intensity.
TMD without Chronic Neck PainAdults diagnosed with temporomandibular disorders (TMD) according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) who had no history of neck pain during the previous 3 months, a VAS score of 0, and a Neck Disability Index (NDI) score of <5. Participants underwent the same clinical assessments as the chronic neck pain group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Mouth Opening

    Maximum interincisal distance (mm) measured using a flexible measuring tape to evaluate temporomandibular joint mobility.

    Measured: Baseline (Cross-sectional assessment)

  2. Jaw Functional Limitation Scale-20 (JFLS-20)

    Functional limitation associated with temporomandibular disorders assessed using the Jaw Functional Limitation Scale-20. The Jaw Functional Limitation Scale-20 consists of 20 items and yields a total score ranging from 0 to 200, with 0 indicating no functional limitation and 200 indicating maximum functional limitation. Lower scores indicate better jaw function (better outcome), whereas higher scores indicate greater functional limitation (worse outcome).

    Measured: Baseline (Cross-sectional assessment)

Secondary outcomes (6)
  1. Craniovertebral Angle

    Cervical proprioception assessed using the Joint Position Error Test. Joint position error is measured in degrees (°) as the absolute repositioning error between the target and reproduced head position. There is no fixed minimum or maximum value. Lower values indicate better cervical proprioceptive function (better outcome), whereas higher values indicate greater repositioning error and poorer cervical proprioceptive function (worse outcome).

    Measured: Baseline (Cross-sectional assessment)

  2. Total Cervical Range of Motion

    Total cervical range of motion measured with the Cervical Range of Motion (CROM) device.

    Measured: Baseline (Cross-sectional assessment)

  3. Deep Cervical Flexor Endurance

    Deep cervical flexor muscle endurance assessed using the Craniocervical Flexion Test.

    Measured: Baseline (Cross-sectional assessment)

  4. Cervical Proprioception

    Cervical proprioception evaluated using the Joint Position Error Test. Lower error values indicate better proprioceptive function.

    Measured: Baseline (Cross-sectional assessment)

  5. Neck Disability Index (NDI)

    Neck-related disability assessed using the Neck Disability Index. The Neck Disability Index is a 10-item questionnaire with total scores ranging from 0 to 50, where 0 indicates no disability and 50 indicates complete disability. Lower scores indicate less neck-related disability (better outcome), whereas higher scores indicate greater neck-related disability (worse outcome).

    Measured: Baseline (Cross-sectional assessment)

  6. Temporomandibular Joint Pain Intensity

    Temporomandibular joint pain intensity assessed using the 10-centimeter Visual Analog Scale. The Visual Analog Scale ranges from 0 to 10 centimeters, where 0 indicates no pain and 10 indicates the worst imaginable pain. Lower scores indicate lower pain intensity (better outcome), whereas higher scores indicate greater pain intensity (worse outcome).

    Measured: Baseline (Cross-sectional assessment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2026
  2. Study start23 Jun 2026
  3. Primary completion6 Jul 2026
  4. Study completion15 Jul 2026

Resources

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-control
Time perspective
Cross-sectional
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07750743
Sponsor's protocol ID
2026/8-11
Status last verified
Aug 2026
First submitted
2 Aug 2026
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Park Y, Lee T, Seog M, Kim SO, Kim J, Kwon JS, Kang CM. An Analysis of the Temporomandibular Joint Range of Motion and Related Factors in Children and Adolescents. Children (Basel). 2021 Jun 17;8(6):515. doi: 10.3390/children8060515.

    PubMed 34204551

Questions about this trial

What is this clinical trial studying?

An observational study of Temporomandibular Disorders, run by Hacettepe 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 10 Aug 2026. 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?

Maximum Mouth Opening (time frame: Baseline (Cross-sectional assessment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07750743, which also lists 1 linked publication.

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 10 Aug 2026.

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