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Temporomandibular Dysfunction (TMD)NCT07681570

Cervical Proprioception, Masticatory Pain Threshold and Craniovertebral Angle in TMD

An observational study of Temporomandibular Dysfunction (TMD), run by Ankara Yildirim Beyazıt 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 disorder (TMD) is a group of conditions involving the masticatory muscles, temporomandibular joint (TMJ), and associated structures of the head, neck, and cervical region. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Temporomandibular Dysfunction (TMD)
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2026to 25 Jun 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Ankara Yıldırım Beyazıt University Faculty of Health Sciences

Who may be able to join

  • Temporomandibular dysfunction group:
  • Volunteering to take part in the study
  • Scoring over 15 on the Fonseca scale
  • Being aged 18 or over
  • Healthy group:
  • Willingness to participate in the study, Fonseca score of 15 or below
  • Being aged 18 or over.

Who cannot join

  • Temporomandibular dysfunction group:
  • Having undergone any medical treatment or physiotherapy for the temporomandibular joint within the last 6 months
  • A history of spinal surgery
  • Neuropathy involving the cervical region
  • A herniated disc and additional conditions that may cause pain
  • Having any neurological or rheumatological condition
Show all 10Show fewer
  • Healthy group:
  • A history of spinal surgery
  • Cervical spine pathologies
  • Having any neurological or rheumatological condition

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Yıldırım Beyazıt University,Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: A Comparison of Cervical Region Position Sensation, Masticatory Muscle Pain Threshold, and the Craniovertebral Angle in Individuals With Temporomandibular Joint Dysfunction and Healthy Individuals

Temporomandibular disorder (TMD) is a group of conditions involving the masticatory muscles, temporomandibular joint (TMJ), and associated structures of the head, neck, and cervical region. TMD may cause pain in the ear region and over the masseter muscle, restricted mandibular movement, and clicking or crepitus sounds in the temporomandibular joint. It may also be accompanied by cervical dysfunction, limited range of motion, pain, and postural abnormalities. Due to the close anatomical and functional relationship between the cervical region and the TMJ, disorders affecting one region are likely to influence the other. Alterations in the TMJ may lead to changes in the cervical spine and consequently affect proprioception. Head posture can be evaluated using the craniovertebral angle. Increases or decreases in this angle may reflect changes in anterior head tilt. Cervical impairments associated with TMD may also result in alterations in the craniovertebral angle. Therefore, the aim of this study is to compare cervical joint position sense, pressure pain threshold of the masticatory muscles, and craniovertebral angle values between individuals with TMD and healthy controls.

Read the detailed description

Temporomandibular disorder (TMD) is a condition affecting the temporomandibular joint (TMJ), masticatory muscles, and associated structures. Patients with TMD may present with a variety of symptoms, including pain, headache, joint locking, limited mouth opening, and joint sounds. Because the cervical vertebrae are anatomically and functionally connected to the cranium and masticatory structures through neurovascular components, muscles, and joints, alterations in one region may influence the other. Shortening of the cervical extensor muscles and the sternocleidomastoid muscle may contribute to the development of a forward head posture, which is associated with increased cervical lordosis. The primary clinical manifestation of TMD is pain related to mandibular movement limitation and joint sounds during function. In addition, TMD-related pain has been reported to be associated with increased psychological distress, autonomic dysfunction, motor impairments, balance deficits, and sleep disturbances. The craniovertebral angle is defined as the angle formed between a horizontal line and a line connecting the tragus of the ear to the spinous process of the seventh cervical vertebra . It is widely used to assess head posture. In a study evaluating cranio-cervical posture using lateral radiographs, Joy et al. reported that individuals with TMD had significantly greater craniovertebral angles than healthy individuals. Proprioception is the ability to perceive joint position and movement without visual input and plays an essential role in maintaining postural balance. Proprioceptors are particularly abundant in the cervical region. Damage or dysfunction affecting the cervical spine may disrupt proprioceptive input, leading to altered head and body position, impaired postural reflexes, and deficits in balance and gait. Based on the current literature, no previous study has simultaneously compared cervical joint position sense, craniovertebral angle, and the pressure pain threshold of the masticatory muscles between individuals with TMD and healthy controls. Therefore, this study was designed to investigate these parameters comprehensively and to contribute to the existing literature.

Keywords
temporomandibular dysfunciton, pain threshold, proprioception, pain
Medical subject headings
Temporomandibular Joint Disorders, Pain

What participants receive

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

Study groups in NCT07681570
Study groupRoleWhat they receive
temporomandibular dysfunction groupThe study sample will consist of individuals with temporomandibular disorder and healthy controls from the Faculty of Health Sciences at Ankara Yıldırım Beyazıt University. Individuals who voluntarily agree to participate will be included in the study.
Healthy groupThe study sample will consist of individuals with temporomandibular disorder and healthy controls from the Faculty of Health Sciences at Ankara Yıldırım Beyazıt University. Individuals who voluntarily agree to participate will be included in the study.

What is being measured

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

  1. pain threshold

    Pressure pain threshold (PPT) of the temporalis and masseter muscles will be assessed using a digital algometer (J-Tech Commander Algometer, Preston Co., USA), an objective measurement device. Participants will be instructed to lie comfortably in the supine position. To familiarize them with the sensation of pressure, pressure will first be applied to an area that is not included in the assessment. During the evaluation, participants will be instructed to raise one hand when the applied pressure first becomes uncomfortable or painful. The algometer will then be applied perpendicularly to the predetermined assessment points: bilaterally over the masseter muscle (1 cm superior and 2 cm anterior to the mandibular angle) and bilaterally over the temporalis muscle (2 cm superior to the zygomatic arch, between the lateral canthus of the eye and the anterior aspect of the ear). The value displayed on the algometer at the moment the participant reports pain will be recorded in kg/cm². A one-m

    Measured: Day 1

  2. pain intensity

    Pain associated with TMD will be assessed using the Visual Analog Scale (VAS). Participants will be asked to indicate the intensity of pain perceived in both temporomandibular joints (TMJs). The VAS, developed by Max Freyd, is one of the most widely used methods for pain assessment. It consists of a 100-mm horizontal line with two anchor points representing the extremes of the parameter being measured. Participants will be instructed to mark the point on the line that best reflects their perceived pain intensity. They will be informed that 0 cm represents "no pain" and 10 cm represents "the worst imaginable pain."

    Measured: Day 1

  3. sense of joint position in the cervical region

    Joint position sense (JPS) will be assessed using an Acumar Dual Digital Inclinometer® (Acu360, Acumar, Lafayette, IN, USA). Cervical joint position sense will be evaluated during flexion, extension, right and left lateral flexion, and right and left rotation at a target angle of 30°. This target angle was selected based on the normal range of cervical motion to minimize the influence of soft tissue tension surrounding the joint on joint position sense. First, the examiner will position the participant at the target angle, where the position will be maintained for 2 seconds to allow the participant to memorize it. The participant will then be passively returned to the neutral position and instructed to actively reproduce the target angle. Each movement will be performed three times with the participant's eyes closed, and the mean value of the three trials will be used for analysis.

    Measured: Day 1

Secondary outcomes (1)
  1. craniovertebral angle

    The craniovertebral angle will be measured using digital image analysis of a lateral-view photograph obtained while each participant is seated on the same standardized chair. Participants will be instructed to sit comfortably with their thoracic and lumbar regions in contact with the backrest, their eyes facing forward, and both feet placed flat on the floor with the knees flexed at 90°. To facilitate image analysis, a reflective marker will be attached over the spinous process of the seventh cervical vertebra (C7) using adhesive tape, and the tragus of the ear will be clearly visible in the photograph. The C7 spinous process will be identified by palpation during active cervical rotation. The images will be analyzed using Kinovea software (version 0.8.15). The craniovertebral angle will be defined as the angle formed between a horizontal line passing through the C7 spinous process and a line connecting the C7 spinous process to the tragus of the ear.

    Measured: Day 1

Timeline

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

  1. First posted2 Jul 2026
  2. Study start1 Jun 2026
  3. Primary completion20 Jun 2026
  4. Study completion25 Jun 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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07681570
Sponsor's protocol ID
01/1105
Status last verified
Jun 2026
First submitted
26 Jun 2026
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to privacy and confidentiality concerns.

Publications

  • Ohrbach R, Gale EN. Pressure pain thresholds in normal muscles: reliability, measurement effects, and topographic differences. Pain. 1989 Jun;37(3):257-263. doi: 10.1016/0304-3959(89)90189-9.

    PubMed 2755707
  • Ozdinc S PhD, Ata H MSc, Selcuk H MSc, Can HB MSc, Sermenli N MSc, Turan FN PhD. Temporomandibular joint disorder determined by Fonseca anamnestic index and associated factors in 18- to 27-year-old university students. Cranio. 2020 Sep;38(5):327-332. doi: 10.1080/08869634.2018.1513442. Epub 2018 Sep 8.

    PubMed 30198391
  • Akbaş, E., Erdem, E. U., & Ünver, B. (2019). Depresyon düzeyinin boyun ağrısı, eklem hareket açıklığı ve servikal eklem pozisyon hissine etkisi. Sağlık Bilimleri ve Meslekleri Dergisi, 6(3), 555-563.

  • Zárate-Tejero, C. A., Rodríguez-Rubio, P. R., Brandt, L., Krauss, J., Hernández-Secorún, M., Hidalgo-García, C., & Lucha-López, O. (2024). Measuring Craniovertebral Angle Reference Values in Adults Using Kinovea Software. Applied Sciences, 14(19), 8639. https://doi.org/10.3390/app14198639

  • Wieckiewicz W, Wozniak K, Piatkowska D, Szyszka-Sommerfeld L, Lipski M. The diagnostic value of pressure algometry for temporomandibular disorders. Biomed Res Int. 2015;2015:575038. doi: 10.1155/2015/575038. Epub 2015 Mar 26.

    PubMed 25883964
  • Iunes, D. H., Carvalho, L. C. F., Oliveira, A. S., & Bevilaqua- Grossi, D. (2009). Craniocervical posture analysis in patients with temporomandibular disorder. Brazilian Journal of Physical Therapy, 13, 89-95. 13-) Oliveira, S. S. I., Pannuti, C. M., Paranhos, K. S., Tanganeli, J. P. C., Laganá, D. C., Sesma, N.,

  • Joy TE, Tanuja S, Pillai RR, Dhas Manchil PR, Raveendranathan R. Assessment of craniocervical posture in TMJ disorders using lateral radiographic view: A cross-sectional study. Cranio. 2021 Sep;39(5):391-397. doi: 10.1080/08869634.2019.1665227. Epub 2019 Sep 13.

    PubMed 31516098
  • Cuccia A, Caradonna C. The relationship between the stomatognathic system and body posture. Clinics (Sao Paulo). 2009;64(1):61-6. doi: 10.1590/s1807-59322009000100011.

    PubMed 19142553
  • Cuenca-Martinez F, Herranz-Gomez A, Madronero-Miguel B, Reina-Varona A, La Touche R, Angulo-Diaz-Parreno S, Pardo-Montero J, Del Corral T, Lopez-de-Uralde-Villanueva I. Craniocervical and Cervical Spine Features of Patients with Temporomandibular Disorders: A Systematic Review and Meta-Analysis of Observational Studies. J Clin Med. 2020 Aug 30;9(9):2806. doi: 10.3390/jcm9092806.

    PubMed 32872670
  • Balthazard P, Hasler V, Goldman D, Grondin F. Association of cervical spine signs and symptoms with temporomandibular disorders in adults: a systematic review protocol. JBI Evid Synth. 2020 Jun;18(6):1334-1340. doi: 10.11124/JBISRIR-D-19-00107.

    PubMed 32813383
  • Wadhokar OC, Patil DS. Current Trends in the Management of Temporomandibular Joint Dysfunction: A Review. Cureus. 2022 Sep 19;14(9):e29314. doi: 10.7759/cureus.29314. eCollection 2022 Sep.

    PubMed 36277551
  • Tran C, Ghahreman K, Huppa C, Gallagher JE. Management of temporomandibular disorders: a rapid review of systematic reviews and guidelines. Int J Oral Maxillofac Surg. 2022 Sep;51(9):1211-1225. doi: 10.1016/j.ijom.2021.11.009. Epub 2022 Mar 23.

    PubMed 35339331
  • Gauer RL, Semidey MJ. Diagnosis and treatment of temporomandibular disorders. Am Fam Physician. 2015 Mar 15;91(6):378-86.

    PubMed 25822556

Questions about this trial

What is this clinical trial studying?

An observational study of Temporomandibular Dysfunction (TMD), run by Ankara Yildirim Beyazıt 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 7 inclusion and 10 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 6 Jul 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?

pain threshold (time frame: Day 1). The study lists 3 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 NCT07681570, which also lists 13 linked publications.

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 6 Jul 2026.

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