Temporomandibular Joint DisordersNCT06472141
Effectiveness of Cervical Stabilization Exercises in Individuals With Temporomandibular Joint Disorder
A study testing Cervical stabilization exercises and Standard treatment (Education + home exercises) in people with Temporomandibular Joint Disorders, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial summary
It is planned to examine the effect of cervical stabilization exercises on Temporomandibular Joint (TMJ) symptoms in individuals with TMJ disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Cervical stabilization exercises and Standard treatment (Education + home exercises)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jun 2024to 21 Mar 2025
- Phase
- Interventional
- 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
Who may be able to join
- Having a TMJ disorder according to the TMJ Disorders Research Diagnostic Criteria (RDC/TMD),
- Being between the ages of 18-65,
Who cannot join
- Neurological diseases (such as Multiple Sclerosis, Parkinson's disease),
- Metabolic and systemic diseases (such as Hypothyroidism, Hypercalcemia, Diabetes mellitus, Celiac disease),
- Rheumatologic diseases (such as Rheumatoid arthritis, Scleroderma),
- History of head and spine trauma/surgery in the last 6 months,
- History of malignancy and pregnant women will be excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bitlis Eren Üniversitesi
Merkez, Bitlis, 13000
About this study
It is planned to examine the effect of cervical stabilization exercises on Temporomandibular Joint (TMJ) symptoms in individuals with TMJ disorder.
Read the detailed description
Individuals included in the study will be divided into 2 groups, Stabilization and Control groups, by block randomization method. A standard treatment program (Education + home exercises) will be applied to both groups. In addition to the stabilization group, cervical stabilization exercises will be applied. Individuals will be evaluated with the Sociodemographic Data Form before the application.
Before and after the application, individuals were assessed for TMJ pain with the Numeric Pain Rating Scale (NPRS), TMJ symptom severity with the Fonseca Anamnestic Index (FAI) and cervical posture, mobility and muscle performance will be evaluated with craniovertebral angle, goniometer and craniocervical flexion test.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Cervical stabilization exercises, Standard treatment (Education + home exercises)
- Keywords
- Temporomandibular Joint Disorders
- 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.
Cervical stabilization exercisesOther
Cervical Stabilization Exercises will be performed 3 days a week for 8 weeks.
Standard treatment (Education + home exercises)Other
Individuals will be informed about TMJ disorders, parafunctional activities (chewing gum, nail/pen biting, etc.) and recommendations. In addition, Rocabado exercises will be given as a home program.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The control group will receive a standard treatment (education + home exercises) program. Receives: Other: Standard treatment (Education + home exercises) |
| Stabilization group | Experimental | The stabilization group will receive cervical stabilization exercises in addition to standard treatment. Receives: Other: Cervical stabilization exercises; Other: Standard treatment (Education + home exercises) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
TMJ pain will be evaluated at rest with the NPRS scale. It is a scale scored between 0-10 points and '0 points means 'I have no pain' and '10 points means 'I have unbearable pain'. NRS score between 1-3 points indicates mild pain, between 4-6 points indicates moderate pain and between 7-10 points indicates severe pain.
Measured: Change from baseline at 8 weeks
Fonseca Anamnestic Index (FAI)
It assesses TMJ disorder and its severity. The index includes three options: "yes" (10 points), "sometimes" (5 points) and "no" (0 points). A total score of 0-15 is considered as no TMJ disorder, 20-40 as mild, 45-65 as moderate, and 70-100 as severe.
Measured: Change from baseline at 8 weeks
Cervical Posture
Cervical posture will be evaluated from the craniovertebral angle.
Measured: Change from baseline at 8 weeks
Cervical Mobility
For cervical mobility, normal joint movements of the neck will be evaluated with a goniometer.
Measured: Change from baseline at 8 weeks
Cervical Muscle Performance
Cervical muscle performance will be evaluated with the craniocervical flexion test.
Measured: Change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start24 Jun 2024
- Primary completion21 Mar 2025
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was planned as a randomized controlled trial. The individuals included in the study will be divided into 2 groups as Stabilization and Control group by block randomization method.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut Arslan, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472141
- Sponsor's protocol ID
- TMJD-EXERCISE
- Status last verified
- Mar 2025
- First submitted
- 10 Jun 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arslan M, Dursun O, Celenay ST. Effectiveness of cervical stabilization training in individuals with temporomandibular joint disorders: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Aug 14;26(1):788. doi: 10.1186/s12891-025-09055-3.
PubMed 40813998
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cervical Stabilization Exercises in Individuals With Temporomandibular Joint Disorder
- ClinicalTrials.gov ID
- NCT06472141
- Acronym / sponsor ID
- TMJD-EXERCISE
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Temporomandibular Joint Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 24 Jun 2024 (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.
It is planned to examine the effect of cervical stabilization exercises on Temporomandibular Joint (TMJ) symptoms in individuals with TMJ disorder.
Detailed description
Individuals included in the study will be divided into 2 groups, Stabilization and Control groups, by block randomization method. A standard treatment program (Education + home exercises) will be applied to both groups. In addition to the stabilization group, cervical stabilization exercises will be applied. Individuals will be evaluated with the Sociodemographic Data Form before the application.
Before and after the application, individuals were assessed for TMJ pain with the Numeric Pain Rating Scale (NPRS), TMJ symptom severity with the Fonseca Anamnestic Index (FAI) and cervical posture, mobility and muscle performance will be evaluated with craniovertebral angle, goniometer and craniocervical flexion test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was planned as a randomized controlled trial. The individuals included in the study will be divided into 2 groups as Stabilization and Control group by block randomization method.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Standard treatment (Education + home exercises)The control group will receive a standard treatment (education + home exercises) program. |
| Stabilization group | Experimental | Other: Cervical stabilization exercises, Other: Standard treatment (Education + home exercises)The stabilization group will receive cervical stabilization exercises in addition to standard treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having a TMJ disorder according to the TMJ Disorders Research Diagnostic Criteria (RDC/TMD),
- Being between the ages of 18-65,
Key exclusion criteria (5 listed)
- Neurological diseases (such as Multiple Sclerosis, Parkinson's disease),
- Metabolic and systemic diseases (such as Hypothyroidism, Hypercalcemia, Diabetes mellitus, Celiac disease),
- Rheumatologic diseases (such as Rheumatoid arthritis, Scleroderma),
- History of head and spine trauma/surgery in the last 6 months,
- History of malignancy and pregnant women will be excluded.
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 |
|---|---|---|
| Cervical stabilization exercisesCervical Stabilization Exercises will be performed 3 days a week for 8 weeks. | Other | Stabilization group |
| Standard treatment (Education + home exercises)Individuals will be informed about TMJ disorders, parafunctional activities (chewing gum, nail/pen biting, etc.) and recommendations. In addition, Rocabado exercises will be given as a home program. | Other | Control group, Stabilization group |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: Change from baseline at 8 weeks
TMJ pain will be evaluated at rest with the NPRS scale. It is a scale scored between 0-10 points and '0 points means 'I have no pain' and '10 points means 'I have unbearable pain'. NRS score between 1-3 points indicates mild pain, between 4-6 points indicates moderate pain and between 7-10 points indicates severe pain.
Fonseca Anamnestic Index (FAI)
Time frame: Change from baseline at 8 weeks
It assesses TMJ disorder and its severity. The index includes three options: "yes" (10 points), "sometimes" (5 points) and "no" (0 points). A total score of 0-15 is considered as no TMJ disorder, 20-40 as mild, 45-65 as moderate, and 70-100 as severe.
Cervical Posture
Time frame: Change from baseline at 8 weeks
Cervical posture will be evaluated from the craniovertebral angle.
Cervical Mobility
Time frame: Change from baseline at 8 weeks
For cervical mobility, normal joint movements of the neck will be evaluated with a goniometer.
Cervical Muscle Performance
Time frame: Change from baseline at 8 weeks
Cervical muscle performance will be evaluated with the craniocervical flexion test.
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 26 Mar 2025.
- Derived from this study: PubMed 40813998Arslan M, Dursun O, Celenay ST. Effectiveness of cervical stabilization training in individuals with temporomandibular joint disorders: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Aug 14;26(1):788. doi: 10.1186/s12891-025-09055-3.
- Individual participant dataSharing planned: No
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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?
A study testing Cervical stabilization exercises and Standard treatment (Education + home exercises) in people with Temporomandibular Joint Disorders, run by Bitlis Eren 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 2 inclusion and 5 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 26 Mar 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 Rating Scale (NPRS) (time frame: Change from baseline at 8 weeks). 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?
On the ClinicalTrials.gov record for NCT06472141, which also lists 1 linked publication.
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 26 Mar 2025.