Temporomandibular Disorders (TMD)NCT06937502
Functionality and Clinical Correlates in TMD
An observational study of Temporomandibular Disorders (TMD) and Functional Limitation, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Temporomandibular disorders (TMD) are among the most common causes of orofacial pain and refer to structural and functional impairments related to the masticatory muscles, surrounding soft tissues, and/or the temporomandibular joint (TMJ). They negatively affect individuals physically, psychologically, and socially. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Temporomandibular Disorders (TMD), Functional Limitation, Pain Severity
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2025to 10 Aug 2025
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study will include individuals aged 18-55 diagnosed with temporomandibular disorders (TMD) who present at least one main symptom (jaw pain, limited mouth opening, or TMJ sounds), have a VAS pain score ≥3, and an MMSE score ≥24. Participation will be voluntary with informed consent. Exclusion criteria include history of head/neck surgery, trauma, cancer treatment, significant tooth loss, dental prosthesis use, ongoing tooth pain, current medication affecting pain perception, previous orthodontic or TMD-specific treatment, and diagnosis of disc displacement without reduction.
Who may be able to join
- Voluntary participation in the study
- Aged between 18 and 55 years
- Diagnosed with temporomandibular disorders (TMD) and exhibiting at least one of the three main symptoms (jaw pain, limited mouth opening, and/or temporomandibular joint sound)
- A Mini-Mental State Examination (MMSE) score of 24 or higher
- Pain score of 3 or above on the Visual Analog Scale (VAS)
Who cannot join
- History of complex surgery, trauma, chemoradiotherapy, and/or tumors involving the head and neck region
- Ongoing use of analgesics, anti-inflammatory or psychiatric medications, and/or substance abuse
- Significant tooth loss that interferes with chewing function
- Use of dental prosthesis
- Ongoing tooth pain
- Receiving any TMD-specific treatment prior to or during the evaluation period
- History of orthodontic treatment
- Diagnosis of disc displacement without reduction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Functionality and Pain, Range of Motion, Neck Disability, and Quality of Life in Temporomandibular Disorders: A Cross-Sectional Study
Temporomandibular disorders (TMD) are among the most common causes of orofacial pain and refer to structural and functional impairments related to the masticatory muscles, surrounding soft tissues, and/or the temporomandibular joint (TMJ). They negatively affect individuals physically, psychologically, and socially. The structural and functional impairments observed in TMD typically manifest as pain, restricted jaw movement, joint sounds, and muscle tension. In addition to these core symptoms, secondary issues such as chewing difficulties may also occur. Pain in TMD can negatively impact many orofacial functions, especially chewing. Functional impairment in individuals with TMD may result from pain, restricted jaw mobility, muscle tension, alterations in muscle activation, mandibular asymmetry, and morphological changes in the joint. These findings highlight the importance of addressing factors associated with functional impairment in individuals with TMD.
Pain severity is strongly associated with functional limitations of the TMJ and neck disability. Particularly in cases of muscular-origin TMD, significant impairments in neck muscle function and joint mobility have been observed. This condition directly affects jaw function and leads to a decrease in quality of life. The impact of TMD on quality of life is directly related to pain severity and functional limitations. As pain severity increases, limitations in daily activities and reductions in overall quality of life also increase. Therefore, a multidisciplinary approach to TMD is essential for pain management, functional rehabilitation, and improving quality of life.
The aim of this study is to investigate the relationships between functionality and pain, range of motion, neck disability, and quality of life in individuals with TMD. Understanding these relationships will form a basis for the effective management of TMD and improving individuals' quality of life.
- Conditions
- Temporomandibular Disorders (TMD), Functional Limitation, Pain Severity, Neck Disability, Quality of Life
- 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 group | Role | What they receive |
|---|---|---|
| Temporomandibular Disorders - Functionality Study Group | Mandibular functionality will be assessed using the Mandibular Function Impairment Questionnaire. Active temporomandibular joint (TMJ) range of motion (ROM) will be measured with a caliper. Pain will be evaluated using the Visual Analog Scale (VAS), neck disability using the Neck Disability Index (NDI), and quality of life using the World Health Organization Quality of Life Questionnaire (WHOQOL). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporomandibular Joint Functionality Assessment
The Mandibular Function Impairment Questionnaire (MFIQ) will be used to assess mandibular functionality. The MFIQ is designed to evaluate the patient's perception of mandibular functional impairment. It consists of 17 items, each rated on a 5-point Likert scale, with a total score ranging from 0 to 68. The questionnaire reflects the difficulty experienced during specific movements or tasks. Higher scores indicate greater functional impairment of the mandible.
Measured: At baseline
Temporomandibular Joint Range of Motion Assessment
Active range of motion (ROM) will be evaluated. A caliper will be used to measure maximal mouth opening. For this assessment, the participant will be instructed to open their mouth as wide as possible. The movement will be repeated three times, and during the third repetition, the distance between the upper and lower central incisors will be measured and recorded.
Measured: At baseline
Pain Assessment
The Visual Analog Scale (VAS) will be used to measure the intensity of pain. This scale includes numbers ranging from 0 to 10, where "0" indicates no pain and "10" represents the worst pain imaginable. The participant will be informed that the pain intensity increases along the scale from 0 to 10 and will be asked to mark the point that best represents the severity of pain they are experiencing.
Measured: At baseline
Neck Disability Assessment
The Neck Disability Index (NDI) will be used to determine the level of neck disability in participants. The scale consists of ten items, covering topics such as neck pain intensity, personal care, lifting, reading, headaches, concentration, driving, sleeping, and recreational activities. Each item contains six response options that assess the degree of pain and limitation. Scoring ranges from 0 to 5 for each item, with a total score ranging from 0 to 50. Based on the total score, disability levels are classified as follows:
0-4 = no disability, 5-14 = mild disability, 15-24 = moderate disability, 25-34 = severe disability, 35 and above = complete disability.
Measured: At baseline
Quality of Life Assessment
The World Health Organization Quality of Life Scale (WHOQOL-BREF) evaluates five main domains: general health, physical health, psychological well-being, social relationships, and environment. It includes parameters such as pain, sleep, energy (physical health); positive feelings, self-esteem, body image (psychological health); social support and personal relationships (social health); and financial resources, transportation, safety, and access to healthcare (environmental health). The scale uses a 5-point Likert system, ranging from "1 = Very Dissatisfied" to "5 = Very Satisfied." Higher scores indicate a better quality of life.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start10 Jun 2025
- Primary completion15 Jul 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Kabasakal, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937502
- Sponsor's protocol ID
- ISU-2025-003
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Functionality and Pain, Range of Motion, Neck Disability, and Quality of Life in Temporomandibular Disorders: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06937502
- Acronym / sponsor ID
- ISU-2025-003
- Conditions
- Temporomandibular Disorders (TMD), Functional Limitation, Pain Severity, Neck Disability, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 22 Apr 2025 (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.
Temporomandibular disorders (TMD) are among the most common causes of orofacial pain and refer to structural and functional impairments related to the masticatory muscles, surrounding soft tissues, and/or the temporomandibular joint (TMJ). They negatively affect individuals physically, psychologically, and socially. The structural and functional impairments observed in TMD typically manifest as pain, restricted jaw movement, joint sounds, and muscle tension. In addition to these core symptoms, secondary issues such as chewing difficulties may also occur. Pain in TMD can negatively impact many orofacial functions, especially chewing. Functional impairment in individuals with TMD may result from pain, restricted jaw mobility, muscle tension, alterations in muscle activation, mandibular asymmetry, and morphological changes in the joint. These findings highlight the importance of addressing factors associated with functional impairment in individuals with TMD.
Pain severity is strongly associated with functional limitations of the TMJ and neck disability. Particularly in cases of muscular-origin TMD, significant impairments in neck muscle function and joint mobility have been observed. This condition directly affects jaw function and leads to a decrease in quality of life. The impact of TMD on quality of life is directly related to pain severity and functional limitations. As pain severity increases, limitations in daily activities and reductions in overall quality of life also increase. Therefore, a multidisciplinary approach to TMD is essential for pain management, functional rehabilitation, and improving quality of life.
The aim of this study is to investigate the relationships between functionality and pain, range of motion, neck disability, and quality of life in individuals with TMD. Understanding these relationships will form a basis for the effective management of TMD and improving individuals' quality of life.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temporomandibular Disorders - Functionality Study Group | – | –Mandibular functionality will be assessed using the Mandibular Function Impairment Questionnaire. Active temporomandibular joint (TMJ) range of motion (ROM) will be measured with a caliper. Pain will be evaluated using the Visual Analog Scale (VAS), neck disability using the Neck Disability Index (NDI), and quality of life using the World Health Organization Quality of Life Questionnaire (WHOQOL). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study will include individuals aged 18-55 diagnosed with temporomandibular disorders (TMD) who present at least one main symptom (jaw pain, limited mouth opening, or TMJ sounds), have a VAS pain score ≥3, and an MMSE score ≥24. Participation will be voluntary with informed consent. Exclusion criteria include history of head/neck surgery, trauma, cancer treatment, significant tooth loss, dental prosthesis use, ongoing tooth pain, current medication affecting pain perception, previous orthodontic or TMD-specific treatment, and diagnosis of disc displacement without reduction.
Key inclusion criteria (5 listed)
- Voluntary participation in the study
- Aged between 18 and 55 years
- Diagnosed with temporomandibular disorders (TMD) and exhibiting at least one of the three main symptoms (jaw pain, limited mouth opening, and/or temporomandibular joint sound)
- A Mini-Mental State Examination (MMSE) score of 24 or higher
- Pain score of 3 or above on the Visual Analog Scale (VAS)
Key exclusion criteria (8 listed)
- History of complex surgery, trauma, chemoradiotherapy, and/or tumors involving the head and neck region
- Ongoing use of analgesics, anti-inflammatory or psychiatric medications, and/or substance abuse
- Significant tooth loss that interferes with chewing function
- Use of dental prosthesis
- Ongoing tooth pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Temporomandibular Joint Functionality Assessment
Time frame: At baseline
The Mandibular Function Impairment Questionnaire (MFIQ) will be used to assess mandibular functionality. The MFIQ is designed to evaluate the patient's perception of mandibular functional impairment. It consists of 17 items, each rated on a 5-point Likert scale, with a total score ranging from 0 to 68. The questionnaire reflects the difficulty experienced during specific movements or tasks. Higher scores indicate greater functional impairment of the mandible.
Temporomandibular Joint Range of Motion Assessment
Time frame: At baseline
Active range of motion (ROM) will be evaluated. A caliper will be used to measure maximal mouth opening. For this assessment, the participant will be instructed to open their mouth as wide as possible. The movement will be repeated three times, and during the third repetition, the distance between the upper and lower central incisors will be measured and recorded.
Pain Assessment
Time frame: At baseline
The Visual Analog Scale (VAS) will be used to measure the intensity of pain. This scale includes numbers ranging from 0 to 10, where "0" indicates no pain and "10" represents the worst pain imaginable. The participant will be informed that the pain intensity increases along the scale from 0 to 10 and will be asked to mark the point that best represents the severity of pain they are experiencing.
Neck Disability Assessment
Time frame: At baseline
The Neck Disability Index (NDI) will be used to determine the level of neck disability in participants. The scale consists of ten items, covering topics such as neck pain intensity, personal care, lifting, reading, headaches, concentration, driving, sleeping, and recreational activities. Each item contains six response options that assess the degree of pain and limitation. Scoring ranges from 0 to 5 for each item, with a total score ranging from 0 to 50. Based on the total score, disability levels are classified as follows: 0-4 = no disability, 5-14 = mild disability, 15-24 = moderate disability, 25-34 = severe disability, 35 and above = complete disability.
Quality of Life Assessment
Time frame: At baseline
The World Health Organization Quality of Life Scale (WHOQOL-BREF) evaluates five main domains: general health, physical health, psychological well-being, social relationships, and environment. It includes parameters such as pain, sleep, energy (physical health); positive feelings, self-esteem, body image (psychological health); social support and personal relationships (social health); and financial resources, transportation, safety, and access to healthcare (environmental health). The scale uses a 5-point Likert system, ranging from "1 = Very Dissatisfied" to "5 = Very Satisfied." Higher scores indicate a better quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Disorders (TMD) and Functional Limitation, run by Istinye 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 5 inclusion and 8 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 Feb 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?
Temporomandibular Joint Functionality Assessment (time frame: At baseline). The study lists 5 primary outcomes in all. 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 10 Feb 2026.