Temporomandibular Joint DisordersNCT05993494
Pain, Central Sensitization, Kinesiophobia and Stress Level in Individuals With Temporomandibular Dysfunction
An observational study of Temporomandibular Joint Disorders and Pain, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
Temporomandibular dysfunction (TMD) is a musculoskeletal and neuromuscular system-related condition that affects the masticatory muscles, temporomandibular joint, and other related structures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders, Pain
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 30 May 2025
- How long will I take part?
- 1 Year
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: -Patients diagnosed with Temporomandibular joint disorders
Who may be able to join
- Between the ages of 18-65,
- Having complaints related to TMJ for at least 3 months,
- Patients diagnosed with TMD as a result of clinical and radiological evaluation by the dentist
Who cannot join
- Cognitive problems,
- Any systemic joint or muscle disease (e.g. fibromyalgia, rheumatoid arthritis),
- Serious systemic diseases,
- Any neurological disorder (e.g. trigeminal neuralgia),
- Pregnancy, breastfeeding status,
- Previous treatment for TMJ or orofacial muscle pain
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University
Trabzon, Trabzon, 61000
About this study
Official title: Investigation of the Relationship Between Pain, Central Sensitization, Kinesiophobia and Stress Level in Individuals With Temporomandibular Dysfunction
Temporomandibular dysfunction (TMD) is a musculoskeletal and neuromuscular system-related condition that affects the masticatory muscles, temporomandibular joint, and other related structures. Recent research has focused specifically on pain catastrophe, kinesiophobia, and central sensitization in individuals with TMD. Therefore, the aim of this study is to examine the relationship between pain, central sensitization, kinesiophobia and stress level in individuals with temporomandibular dysfunction.
Read the detailed description
Temporomandibular dysfunction (TMD) is a musculoskeletal and neuromuscular system-related condition that affects the masticatory muscles, temporomandibular joint, and other related structures. Psychological factors are stated as comorbid in individuals with TMD. Individuals with TMD-related pain show higher levels of stress, anxiety, depression, somatic awareness, pain catastrophizing, and kinesiophobia compared to controls. Therefore, recent research has focused on pain catastrophe, kinesiophobia, and central sensitization, especially in individuals with TMD. Therefore, the aim of this study is to examine the relationship between pain, central sensitization, kinesiophobia and stress level in individuals with temporomandibular dysfunction. Ninety patients aged 18-65 years, who have TME-related complaints for at least 3 months, and diagnosed with TMD as a result of clinical and radiological evaluation by a dentist will be included in the study.
- Conditions
- Temporomandibular Joint Disorders, Pain
- Keywords
- Temporomandibular Joint Dysfunction, Pain, central sensitization, kinesiophobia, stress
- Medical subject headings
- Temporomandibular Joint Disorders, Pain, Kinesiophobia
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Scale
Pain Assessment
Measured: through study completion, an average of 1 year
Tampa Scale for Kinesiophobia
Kinesiophobia Assessment for temporomandibular joint dysfunction
Measured: through study completion, an average of 1 year
Perceived Stress Scale
Stress Assessment
Measured: through study completion, an average of 1 year
Central sensitization scale
Central sensitization Assessment
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start15 May 2023
- Primary completion20 Feb 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies 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
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhayat KORKMAZ, Karadeniz Technical University
- Investigators
- Nurhayat Korkmaz, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993494
- Sponsor's protocol ID
- KTU-FTR-2023/6
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2023
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Pain, Central Sensitization, Kinesiophobia and Stress Level in Individuals With Temporomandibular Dysfunction
- ClinicalTrials.gov ID
- NCT05993494
- Acronym / sponsor ID
- KTU-FTR-2023/6
- Conditions
- Temporomandibular Joint Disorders, Pain
- Keywords
- Temporomandibular Joint Dysfunction, Pain, central sensitization, kinesiophobia, stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 15 Aug 2023 (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 dysfunction (TMD) is a musculoskeletal and neuromuscular system-related condition that affects the masticatory muscles, temporomandibular joint, and other related structures. Recent research has focused specifically on pain catastrophe, kinesiophobia, and central sensitization in individuals with TMD. Therefore, the aim of this study is to examine the relationship between pain, central sensitization, kinesiophobia and stress level in individuals with temporomandibular dysfunction.
Detailed description
Temporomandibular dysfunction (TMD) is a musculoskeletal and neuromuscular system-related condition that affects the masticatory muscles, temporomandibular joint, and other related structures. Psychological factors are stated as comorbid in individuals with TMD. Individuals with TMD-related pain show higher levels of stress, anxiety, depression, somatic awareness, pain catastrophizing, and kinesiophobia compared to controls. Therefore, recent research has focused on pain catastrophe, kinesiophobia, and central sensitization, especially in individuals with TMD. Therefore, the aim of this study is to examine the relationship between pain, central sensitization, kinesiophobia and stress level in individuals with temporomandibular dysfunction. Ninety patients aged 18-65 years, who have TME-related complaints for at least 3 months, and diagnosed with TMD as a result of clinical and radiological evaluation by a dentist will be included in the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- -Patients diagnosed with Temporomandibular joint disorders
Key inclusion criteria (3 listed)
- Between the ages of 18-65,
- Having complaints related to TMJ for at least 3 months,
- Patients diagnosed with TMD as a result of clinical and radiological evaluation by the dentist
Key exclusion criteria (6 listed)
- Cognitive problems,
- Any systemic joint or muscle disease (e.g. fibromyalgia, rheumatoid arthritis),
- Serious systemic diseases,
- Any neurological disorder (e.g. trigeminal neuralgia),
- Pregnancy, breastfeeding status,
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
Numeric Pain Scale
Time frame: through study completion, an average of 1 year
Pain Assessment
Tampa Scale for Kinesiophobia
Time frame: through study completion, an average of 1 year
Kinesiophobia Assessment for temporomandibular joint dysfunction
Perceived Stress Scale
Time frame: through study completion, an average of 1 year
Stress Assessment
Central sensitization scale
Time frame: through study completion, an average of 1 year
Central sensitization Assessment
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 17 Jul 2025.
- Individual participant dataSharing planned: No
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Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
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Marine Lipids Ease Painful TMD
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Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
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R01_Pilot Jaw Muscle Phenotypes
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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.
Nurhayat Korkmaz principal investigator
Karadeniz Technical University
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 Joint Disorders and Pain, run by Karadeniz Technical 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 3 inclusion and 6 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 17 Jul 2025. 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?
Numeric Pain Scale (time frame: through study completion, an average of 1 year). The study lists 4 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 17 Jul 2025.