An Investigation of Cranio-Cervico-Mandibular Factors Predicting the Severity of Temporomandibular Disorders

June 18, 2026 updated by: sevilay seda bas
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Sevilay Seda BAŞ, PhD
  • Phone Number: +90 (312) 906 1683
  • Email: ssbas@aybu.edu.tr

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Ankara Yıldırım Beyazıt University, Department of Physiotherapy and Rehabilitation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Fonseca Anamnestic Index score > 15
  • aged 18 years and older

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Assessments
No intervention was applied.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Single assessment at baseline (cross-sectional evaluation)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cervical Extension Joint Position Sense
Time Frame: Single assessment at baseline (cross-sectional evaluation)
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.
Single assessment at baseline (cross-sectional evaluation)
Cervical Flexion Joint Position Sense
Time Frame: Single assessment at baseline (cross-sectional evaluation)
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.
Single assessment at baseline (cross-sectional evaluation)
Cervical Lateral Flexion Joint Position Sense
Time Frame: Single assessment at baseline (cross-sectional evaluation)
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.
Single assessment at baseline (cross-sectional evaluation)
Cervical Rotation Joint Position Sense
Time Frame: Single assessment at baseline (cross-sectional evaluation)
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.
Single assessment at baseline (cross-sectional evaluation)
Craniovertebral Angle
Time Frame: Single assessment at baseline (cross-sectional evaluation)
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.
Single assessment at baseline (cross-sectional evaluation)
Neck Musculoskeletal Symptoms
Time Frame: Single assessment at baseline (cross-sectional evaluation)
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.
Single assessment at baseline (cross-sectional evaluation)
Mandibular Function Impairment Questionnaire
Time Frame: Single assessment at baseline (cross-sectional evaluation)
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.
Single assessment at baseline (cross-sectional evaluation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
sevilay seda bas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26.10.2024-10/1051

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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