Temporomandibular DisorderNCT07666360
An Investigation of Cranio-Cervico-Mandibular Factors Predicting the Severity of Temporomandibular Disorders
An observational study of Temporomandibular Disorder, run by sevilay seda bas at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional study will examine the relationship between mandibular dysfunction, cervical joint position sense, craniovertebral angle, neck pain, and temporomandibular dysfunction (TMD) severity. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Assessments
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2026to 10 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults aged 18 years or older with a Fonseca Anamnestic Index (FAI) score of 20 or higher who gave written consent were included. Participants were people with jaw (TMJ) and/or neck complaints. People were excluded if they had recent treatment (last 6 months) for the jaw or neck, used pain or muscle relaxant drugs, had previous neck or jaw surgery or major trauma, jaw dislocation or subluxation, missing teeth or dental prostheses, or neurological, rheumatologic, or systemic inflammatory diseases.
Who may be able to join
- Fonseca Anamnestic Index score > 15
- aged 18 years and older
Who cannot join
- Received medical, orthodontic, or physiotherapy treatment targeting the temporomandibular joint and/or cervical region within the past six months
- used analgesic, anti-inflammatory, or muscle relaxant medications
- history of cervical spine or cranio-cervical surgery or major trauma
- a history of facial or TMJ trauma, TMJ subluxation or dislocation
- partial or complete dental prostheses
- had missing teeth
- neurological, rheumatological, or systemic inflammatory diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Yıldırım Beyazıt University, Department of Physiotherapy and Rehabilitation
Ankara
Sevilay Seda BAŞ, +9 0 (312) 906 1683, ssbas@aybu.edu.tr
About this study
This cross-sectional study will examine the relationship between mandibular dysfunction, cervical joint position sense, craniovertebral angle, neck pain, and temporomandibular dysfunction (TMD) severity. TMD severity, mandibular function, cervical proprioception, craniovertebral angle, and neck pain history will be assessed using standardized clinical tools and questionnaires. The study will evaluate the associations between these variables and determine the factors that may predict TMD severity.
- Conditions
- Temporomandibular Disorder
- Being tested
- Assessments
- 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.
AssessmentsOther
No intervention was applied.
| Study group | Role | What they receive |
|---|---|---|
| TMD Symptomatic Participants | Participants with temporomandibular dysfunction (TMD) symptoms will be included in the study. All participants will undergo clinical and questionnaire-based assessments to evaluate mandibular function, cervical joint position sense, craniovertebral angle, neck pain history, and TMD severity. Receives: Other: Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporomandibular Dysfunction Severity
TMD severity will be assessed using the Fonseca Anamnestic Index, which evaluates the severity of temporomandibular dysfunction symptoms. It is a 10-item self-report questionnaire. Each item is scored as "Yes" (10 points), "Sometimes" (5 points), or "No" (0 points), with a total score calculated by summing all items.
Measured: Single assessment at baseline (cross-sectional evaluation)
Secondary outcomes (7)
Cervical Extension Joint Position Sense
Cervical extension joint position sense will be assessed in a sitting position using an Acumar dual digital inclinometer. Participants will be asked to actively move their neck to 30° of cervical extension, memorize the target position, and then reproduce the same angle. The procedure will be repeated three times, and the average absolute error will be recorded.
Measured: Single assessment at baseline (cross-sectional evaluation)
Cervical Flexion Joint Position Sense
Cervical flexion joint position sense will be assessed in a sitting position using an Acumar dual digital inclinometer. Participants will be asked to actively move their neck to 30° of cervical flexion, memorize the target position, and then reproduce the same angle. The procedure will be repeated three times, and the average absolute error will be recorded.
Measured: Single assessment at baseline (cross-sectional evaluation)
Cervical Lateral Flexion Joint Position Sense
Cervical lateral flexion joint position sense will be assessed in a sitting position using an Acumar dual digital inclinometer. Participants will be asked to actively move their neck to 30° of lateral flexion, memorize the target position, and then reproduce the same angle. The procedure will be repeated three times, and the average absolute error will be recorded.
Measured: Single assessment at baseline (cross-sectional evaluation)
Cervical Rotation Joint Position Sense
Cervical rotation joint position sense will be assessed in a supine position using an Acumar dual digital inclinometer. Participants will be asked to actively rotate their head to 50° of cervical rotation, memorize the target position, and then reproduce the same angle. The procedure will be repeated three times, and the mean absolute error will be recorded.
Measured: Single assessment at baseline (cross-sectional evaluation)
Craniovertebral Angle
Craniovertebral angle will be measured using a two-dimensional image analysis method with Kinovea software from standardized lateral photographs. The tragus and C7 vertebra will be used as anatomical reference points to calculate the angle, and the mean of three measurements will be recorded for each participant.
Measured: Single assessment at baseline (cross-sectional evaluation)
Neck Musculoskeletal Symptoms
Musculoskeletal symptoms will be assessed using the Standardized Nordic Musculoskeletal Questionnaire. The questionnaire evaluates the presence of symptoms in different body regions over the past 12 months and past 7 days. Only neck pain-related variables will be used for analysis in line with the study objectives, while other data will be reported descriptively.
Measured: Single assessment at baseline (cross-sectional evaluation)
Mandibular Function Impairment Questionnaire
Mandibular function will be assessed using the Mandibular Function Impairment Questionnaire (MFIQ). The MFIQ is a 17-item self-report scale evaluating functional limitations during activities such as chewing, speaking, and yawning. Each item is scored on a 0-4 Likert scale, with higher scores indicating greater impairment.
Measured: Single assessment at baseline (cross-sectional evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start19 Jun 2026
- Primary completion10 Jul 2026 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- sevilay seda bas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, sevilay seda bas, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666360
- Sponsor's protocol ID
- 26.10.2024-10/1051
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Cranio-Cervico-Mandibular Factors Predicting the Severity of Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT07666360
- Acronym / sponsor ID
- 26.10.2024-10/1051
- Conditions
- Temporomandibular Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- sevilay seda basUniversity, hospital or other
- Study start
- 19 Jun 2026 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 24 Jun 2026 (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 cross-sectional study will examine the relationship between mandibular dysfunction, cervical joint position sense, craniovertebral angle, neck pain, and temporomandibular dysfunction (TMD) severity. TMD severity, mandibular function, cervical proprioception, craniovertebral angle, and neck pain history will be assessed using standardized clinical tools and questionnaires. The study will evaluate the associations between these variables and determine the factors that may predict TMD severity.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMD Symptomatic Participants | – | Other: AssessmentsParticipants with temporomandibular dysfunction (TMD) symptoms will be included in the study. All participants will undergo clinical and questionnaire-based assessments to evaluate mandibular function, cervical joint position sense, craniovertebral angle, neck pain history, and TMD severity. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults aged 18 years or older with a Fonseca Anamnestic Index (FAI) score of 20 or higher who gave written consent were included. Participants were people with jaw (TMJ) and/or neck complaints. People were excluded if they had recent treatment (last 6 months) for the jaw or neck, used pain or muscle relaxant drugs, had previous neck or jaw surgery or major trauma, jaw dislocation or subluxation, missing teeth or dental prostheses, or neurological, rheumatologic, or systemic inflammatory diseases.
Key inclusion criteria (2 listed)
- Fonseca Anamnestic Index score > 15
- aged 18 years and older
Key exclusion criteria (7 listed)
- Received medical, orthodontic, or physiotherapy treatment targeting the temporomandibular joint and/or cervical region within the past six months
- used analgesic, anti-inflammatory, or muscle relaxant medications
- history of cervical spine or cranio-cervical surgery or major trauma
- a history of facial or TMJ trauma, TMJ subluxation or dislocation
- partial or complete dental prostheses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentsNo intervention was applied. | Other | TMD Symptomatic Participants |
Primary outcome
Temporomandibular Dysfunction Severity
Time frame: Single assessment at baseline (cross-sectional evaluation)
TMD severity will be assessed using the Fonseca Anamnestic Index, which evaluates the severity of temporomandibular dysfunction symptoms. It is a 10-item self-report questionnaire. Each item is scored as "Yes" (10 points), "Sometimes" (5 points), or "No" (0 points), with a total score calculated by summing all items.
7 secondary outcomes
Cervical Extension Joint Position Sense
Time frame: Single assessment at baseline (cross-sectional evaluation)
Cervical Flexion Joint Position Sense
Time frame: Single assessment at baseline (cross-sectional evaluation)
Cervical Lateral Flexion Joint Position Sense
Time frame: Single assessment at baseline (cross-sectional evaluation)
Cervical Rotation Joint Position Sense
Time frame: Single assessment at baseline (cross-sectional evaluation)
Craniovertebral Angle
Time frame: Single assessment at baseline (cross-sectional evaluation)
Neck Musculoskeletal Symptoms
Time frame: Single assessment at baseline (cross-sectional evaluation)
Mandibular Function Impairment Questionnaire
Time frame: Single assessment at baseline (cross-sectional evaluation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
Related trials for Temporomandibular Disorder
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
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.
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 Temporomandibular Disorder, run by sevilay seda bas 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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sevilay Seda BAŞ, PhD (+90 (312) 906 1683, ssbas@aybu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporomandibular Dysfunction Severity (time frame: Single assessment at baseline (cross-sectional evaluation)). 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 24 Jun 2026.