- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07666360
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
Study Type
Observational
Enrollment (Estimated)
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
- Name: Sevilay Seda BAŞ, PhD
- Phone Number: +90 (312) 906 1683
- Email: ssbas@aybu.edu.tr
Study Locations
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-
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Ankara, Turkey (Türkiye)
- Recruiting
- Ankara Yıldırım Beyazıt University, Department of Physiotherapy and Rehabilitation
-
Contact:
- Sevilay Seda BAŞ
- Phone Number: +9 0 (312) 906 1683
- Email: ssbas@aybu.edu.tr
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
No intervention was applied.
|
What is the study measuring?
Primary Outcome Measures
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
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
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)
June 19, 2026
Primary Completion (Estimated)
July 10, 2026
Study Completion (Estimated)
July 10, 2026
Study Registration Dates
First Submitted
June 18, 2026
First Submitted That Met QC Criteria
June 18, 2026
First Posted (Actual)
June 24, 2026
Study Record Updates
Last Update Posted (Actual)
June 24, 2026
Last Update Submitted That Met QC Criteria
June 18, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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