Temporomandibular Joint DysfunctionNCT07556510
Telerehabilitation Dual-Task Training in Temporomandibular Joint Dysfunction
A study testing Standard Physiotherapy Program and Dual-Task Training in people with Temporomandibular Joint Dysfunction, run by Ege University.
Trial summary
This randomized controlled trial will be conducted among 18-25-year-old participants who present with temporomandibular joint dysfunction symptoms, including pain, limited range of motion, and joint crepitation. Participants will be randomly allocated into control and intervention groups using block randomization. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Temporomandibular Joint Dysfunction
- What is being tested?
- Standard Physiotherapy Program and Dual-Task Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 16 Jun 2026to 16 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of temporomandibular joint dysfunction according to the
- Temporomandibular Disorders Research Diagnostic Criteria and Diagnostic
- Criteria for Temporomandibular Disorders
- No neurological, orthopedic, or systemic condition that may affect balance
- Ability to comply with a telerehabilitation program
- Willingness to provide written informed consent
- No prior physiotherapy treatment for temporomandibular joint dysfunction
Who cannot join
- Inability to participate in regular exercise or telerehabilitation programs
- Presence of severe systemic diseases (cardiac, rheumatologic, neurological) or other severe chronic conditions
- Presence of psychiatric disorders or cognitive impairment
- Use of medications that may affect balance (such as sedatives)
- History of jaw or dental surgery within the last 6 months
- Receipt of physiotherapy, splint therapy, or similar treatment for temporomandibular joint dysfunction within the last 3-6 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Telerehabilitation-Based Dual-Task Training on Clinical Outcomes in Temporomandibular Joint Dysfunction
This randomized controlled trial will be conducted among 18-25-year-old participants who present with temporomandibular joint dysfunction symptoms, including pain, limited range of motion, and joint crepitation. Participants will be randomly allocated into control and intervention groups using block randomization. The control group will receive a standard physiotherapy program, while the intervention group will additionally perform telerehabilitation-based dual-task exercises. The intervention will last for six weeks, with progressive increases in exercise and cognitive task difficulty. Outcomes will be assessed at baseline and at the end of the 6th week. Primary and secondary outcome measures include pain intensity (Visual Analog Scale), jaw functional limitation (Jaw Functional Limitation Scale-20), oral habits, static balance (Tetrax system), and dynamic balance (Timed Up and Go Test). Within-group and between-group comparisons will be performed. The sample size was calculated using power analysis, resulting in 30 participants in total (15 per group), accounting for potential dropouts.
- Conditions
- Temporomandibular Joint Dysfunction
- Being tested
- Standard Physiotherapy Program, Dual-Task Training
- Keywords
- temporomandibular joint dysfunction, dual-task, pain, balance
- 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.
Standard Physiotherapy ProgramBehavioural
Cervical range of motion exercises, cervical lateral flexion stretching, upper trapezius stretching, pectoral stretching, breathing exercises, seated cervical postural correction exercises, supine and prone cervical postural exercises, postural training exercises, temporomandibular joint (TMJ) rotation control exercises, TMJ opening, closing, protrusion, and retrusion exercises, tongue resting position training, isometric TMJ elevation, depression, and lateral deviation exercises in sitting position, post-isometric relaxation techniques, abdominal strengthening exercises, and back extensor strengthening exercises.
Dual-Task TrainingBehavioural
Backward counting from 200 by threes during cervical range of motion exercises and pectoral stretching, naming cities starting with the letter "A" during supine cervical postural exercises, naming animals starting with the letter "A" during TMJ rotation control exercises, simple arithmetic tasks (addition and subtraction) during isometric TMJ elevation and depression exercises, and more complex arithmetic tasks during lateral deviation exercises in sitting position. Cognitive task difficulty will be progressively increased over time.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physiotherapy and TMJ Exercise Program | Active comparator | Standard Physiotherapy Program Receives: Behavioral: Standard Physiotherapy Program |
| Telerehabilitation-Based Dual-Task Training | Experimental | Standard Physiotherapy Program plus Telerehabilitation-Based Dual-Task Training Receives: Behavioral: Standard Physiotherapy Program; Behavioral: Dual-Task Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity will be assessed using a 10-cm Visual Analog Scale. Participants will rate their pain at rest, during chewing, and at night. Scores range from 0 (no pain) to 10 (worst imaginable pain).
Measured: Measurements will be recorded at baseline and at week 6. Change in pain intensity will be analyzed.
Jaw Functional Limitation
(Jaw Functional Limitation Scale - JFLS-20): Jaw function will be evaluated using the JFLS-20, a 20-item self-report scale assessing functional limitations in mastication, speech, and jaw movement. Each item is scored from 0 (no limitation) to 10 (severe limitation). Higher scores indicate greater functional impairment.
Measured: Assessments will be performed at baseline and week 6.
Secondary outcomes (7)
Temporomandibular Disorder Classification
Temporomandibular joint dysfunction diagnosis and classification will be determined using the Temporomandibular Disorders Research Diagnostic Criteria and Diagnostic Criteria for Temporomandibular Disorders questionnaire, which provides a standardized multidimensional assessment of temporomandibular disorders. This assessment includes evaluation of muscle-related disorders, disc displacement conditions, and degenerative joint diseases, and enables a comprehensive clinical and psychosocial classification of temporomandibular dysfunction.
Measured: Assessment will be performed at baseline.
Oral Habits
Oral Habits Questionnaire: Oral parafunctional habits will be assessed using a 21-item questionnaire evaluating behaviors such as bruxism, nail biting, and gum chewing. Each item is rated on a 0-4 Likert scale, with total scores ranging from 0 to 84. Higher scores indicate more frequent parafunctional habits.
Measured: Assessments will be performed at baseline and week 6.
Dynamic Balance
Functional mobility and dynamic balance will be assessed using the Timed Up and Go Test. The time (in seconds) required to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded. Shorter times indicate better mobility and balance.
Measured: Assessments will be performed at baseline and week 6.
Stability Index (SI)
Static balance will be assessed using the Tetrax system (Sunlight Medical Ltd., Israel). The Stability Index reflects overall postural sway and stability performance. Higher scores indicate poorer stability. Unit of measure: index score.
Measured: Baseline and after 6 weeks
Weight Distribution Index (WDI)
Measured using the Tetrax system, the WDI evaluates the distribution of body weight across four force plates. Higher values indicate asymmetry in weight distribution. Unit of measure: index score.
Measured: Baseline and after 6 weeks
Fourier Harmonic Index (FHI)
The FHI is derived from frequency analysis of postural sway signals obtained via the Tetrax system. It provides information about postural control mechanisms. Unit of measure: index score.
Measured: Baseline and after 6 weeks
Fall Index
The Fall Index estimates the risk of falling based on postural stability parameters measured by the Tetrax system. Higher scores indicate greater fall risk. Unit of measure: index score.
Measured: Baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start16 Jun 2026 (estimated)
- Primary completion16 Oct 2026 (estimated)
- Study completion16 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DysfunctionStudies of the same condition, open and under way.
- More trials run by Ege 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized controlled parallel-group trial with two groups. Participants will be allocated by block randomization to either a control or an intervention group. The control group will receive a standard physiotherapy program including cervical range of motion, stretching, postural, temporomandibular joint mobility and control, isometric, and strengthening exercises. The intervention group will receive the same standard physiotherapy program plus telerehabilitation-based dual-task training involving concurrent physical exercises and cognitive tasks (e.g., counting, category naming, and simple arithmetic).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miray Baser, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556510
- Sponsor's protocol ID
- TMJ2026
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared upon reasonable request after publication of the main study results. De-identified data may be provided to qualified researchers for academic and non-commercial purposes. Data sharing will be subject to ethical approval and data use agreements.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Telerehabilitation-Based Dual-Task Training on Clinical Outcomes in Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT07556510
- Acronym / sponsor ID
- TMJ2026
- Conditions
- Temporomandibular Joint Dysfunction
- Keywords
- temporomandibular joint dysfunction, dual-task, pain, balance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 16 Jun 2026 (estimated)
- Primary completion
- 16 Oct 2026 (estimated)
- Study completion
- 16 Feb 2027 (estimated)
- First posted
- 29 Apr 2026 (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.
This randomized controlled trial will be conducted among 18-25-year-old participants who present with temporomandibular joint dysfunction symptoms, including pain, limited range of motion, and joint crepitation. Participants will be randomly allocated into control and intervention groups using block randomization. The control group will receive a standard physiotherapy program, while the intervention group will additionally perform telerehabilitation-based dual-task exercises. The intervention will last for six weeks, with progressive increases in exercise and cognitive task difficulty. Outcomes will be assessed at baseline and at the end of the 6th week. Primary and secondary outcome measures include pain intensity (Visual Analog Scale), jaw functional limitation (Jaw Functional Limitation Scale-20), oral habits, static balance (Tetrax system), and dynamic balance (Timed Up and Go Test). Within-group and between-group comparisons will be performed. The sample size was calculated using power analysis, resulting in 30 participants in total (15 per group), accounting for potential dropouts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized controlled parallel-group trial with two groups. Participants will be allocated by block randomization to either a control or an intervention group. The control group will receive a standard physiotherapy program including cervical range of motion, stretching, postural, temporomandibular joint mobility and control, isometric, and strengthening exercises. The intervention group will receive the same standard physiotherapy program plus telerehabilitation-based dual-task training involving concurrent physical exercises and cognitive tasks (e.g., counting, category naming, and simple arithmetic).
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy and TMJ Exercise Program | Active comparator | Behavioral: Standard Physiotherapy ProgramStandard Physiotherapy Program |
| Telerehabilitation-Based Dual-Task Training | Experimental | Behavioral: Standard Physiotherapy Program, Behavioral: Dual-Task TrainingStandard Physiotherapy Program plus Telerehabilitation-Based Dual-Task Training |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosis of temporomandibular joint dysfunction according to the
- Temporomandibular Disorders Research Diagnostic Criteria and Diagnostic
- Criteria for Temporomandibular Disorders
- No neurological, orthopedic, or systemic condition that may affect balance
- Ability to comply with a telerehabilitation program
Key exclusion criteria (6 listed)
- Inability to participate in regular exercise or telerehabilitation programs
- Presence of severe systemic diseases (cardiac, rheumatologic, neurological) or other severe chronic conditions
- Presence of psychiatric disorders or cognitive impairment
- Use of medications that may affect balance (such as sedatives)
- History of jaw or dental surgery within the last 6 months
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 |
|---|---|---|
| Standard Physiotherapy ProgramCervical range of motion exercises, cervical lateral flexion stretching, upper trapezius stretching, pectoral stretching, breathing exercises, seated cervical postural correction exercises, supine and prone cervical postural exercises, postural training exercises, temporomandibular joint (TMJ) rotation control exercises, TMJ opening, closing, protrusion, and retrusion exercises, tongue resting position training, isometric TMJ elevation, depression, and lateral deviation exercises in sitting position, post-isometric relaxation techniques, abdominal strengthening exercises, and back extensor strengthening exercises. | Behavioural | Conventional Physiotherapy and TMJ Exercise Program, Telerehabilitation-Based Dual-Task Training |
| Dual-Task TrainingBackward counting from 200 by threes during cervical range of motion exercises and pectoral stretching, naming cities starting with the letter "A" during supine cervical postural exercises, naming animals starting with the letter "A" during TMJ rotation control exercises, simple arithmetic tasks (addition and subtraction) during isometric TMJ elevation and depression exercises, and more complex arithmetic tasks during lateral deviation exercises in sitting position. Cognitive task difficulty will be progressively increased over time. | Behavioural | Telerehabilitation-Based Dual-Task Training |
Primary outcome
Pain Intensity
Time frame: Measurements will be recorded at baseline and at week 6. Change in pain intensity will be analyzed.
Pain intensity will be assessed using a 10-cm Visual Analog Scale. Participants will rate their pain at rest, during chewing, and at night. Scores range from 0 (no pain) to 10 (worst imaginable pain).
Jaw Functional Limitation
Time frame: Assessments will be performed at baseline and week 6.
(Jaw Functional Limitation Scale - JFLS-20): Jaw function will be evaluated using the JFLS-20, a 20-item self-report scale assessing functional limitations in mastication, speech, and jaw movement. Each item is scored from 0 (no limitation) to 10 (severe limitation). Higher scores indicate greater functional impairment.
7 secondary outcomes
Temporomandibular Disorder Classification
Time frame: Assessment will be performed at baseline.
Oral Habits
Time frame: Assessments will be performed at baseline and week 6.
Dynamic Balance
Time frame: Assessments will be performed at baseline and week 6.
Stability Index (SI)
Time frame: Baseline and after 6 weeks
Weight Distribution Index (WDI)
Time frame: Baseline and after 6 weeks
Fourier Harmonic Index (FHI)
Time frame: Baseline and after 6 weeks
Fall Index
Time frame: Baseline and after 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared upon reasonable request after publication of the main study results. De-identified data may be provided to qualified researchers for academic and non-commercial purposes. Data sharing will be subject to ethical approval and data use agreements.
Related trials for Temporomandibular Joint Dysfunction
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Recruiting
Clinical and Electromyographic Assessment of Occlusal Splint Therapy
Temporomandibular Joint Disorders
Recruiting
An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
Temporomandibular Disorder, Orofacial Pain
Enrolling by invitationObservational study
Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
Temporomandibular Joint Disorders
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.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Physiotherapy Program and Dual-Task Training in people with Temporomandibular Joint Dysfunction, run by Ege University.
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 7 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: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serkan Bakırhan, Professor (+90 505 663 18 40, serkan.bakirhan@ege.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Measurements will be recorded at baseline and at week 6. Change in pain intensity will be analyzed.). The study lists 2 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 5 May 2026.