TMDNCT07304557
Effects Exercises in Temporomandibular Joint Disorders on Pain, Joint and Tongue Functions
A study testing Exercise and Manual therapy in people with TMD and TMD/Orofacial Pain, run by Tayfun ISIK at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn if orofacial exercises works to treat temporomandibular disorders in adults. It will also learn about the safety of orofacial exercises on temporomandibular disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- TMD, TMD/Orofacial Pain
- What is being tested?
- Exercise and Manual therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2025to 15 Nov 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 65 aged people
- Not having received physical therapy for the neck or jaw within the past three months.
- No history of surgical or oncological treatment related to the neck or jaw.
- Having a diagnosis of temporomandibular disorder according to the RDC/TMD criteria, specifically Group Ia, Group Ib, or Group IIa under Axis I.
Who cannot join
- Individuals who are pregnant or suspected to be pregnant.
- Individuals with rheumatologic diseases affecting the temporomandibular joint.
- Individuals with a diagnosed psychiatric disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Medipol University
Ankara, ALTINDAG
Gulcan HARPUT, PROF. DR., +90 541 788 33 23, aktasgulcan@gmail.com
About this study
Official title: COMPARISON OF THE EFFECTS OF OROFACIAL AND TONGUE EXERCISES APPLIED AS AN ADDITION TO MYOFUNCTIONAL TREATMENT IN TEMPOROMANDIBULAR JOINT DISORDERS ON PAIN, JOINT AND TONGUE FUNCTIONS: A RANDOMIZED CONTROLLED TRIAL
The goal of this clinical trial is to learn if orofacial exercises works to treat temporomandibular disorders in adults. It will also learn about the safety of orofacial exercises on temporomandibular disorders. The main questions it aims to answer are:
Does orofacial exercises improve function of temporomandibular disorders ? Does orofacial exercises decrease pain in temporomandibular disorders?
Researchers will compare orofacial exercises and manual therapy to manual therapy.
Participants will:
Take manual therapy and orofacial exercises or manual therapy two days in every week for 6 weeks Assessment once every 2 weeks for tests
Read the detailed description
The study will be conducted with two groups. While the control group will receive myofunctional therapy, the intervention group will receive orofacial and tongue exercises in addition to myofunctional therapy. The inclusion of orofacial and tongue exercises in the intervention group constitutes the main hypothesis of the study. The myofunctional therapy consists of home exercises, normal cervical joint movements, and massage techniques targeting the masticatory muscles.
At baseline, participants' eligibility for inclusion will be assessed. Individuals who meet the inclusion criteria will be randomly assigned to one of the two groups using a sealed envelope randomization method. Evaluation of participants will begin with the collection of demographic data. After recording the demographic information, further assessments will be conducted through questionnaires and instrumental measurements.
The first assessment will focus on pain evaluation, using three different methods.
- Numerical Pain Scale (NPS): This scale assesses pain intensity in three different conditions - during chewing, at rest, and during sleep. Participants will rate their pain on a scale from "0" (no pain) to "10" (worst imaginable pain).
- Pain Catastrophizing Scale (PCS): This self-administered questionnaire evaluates the participant's thoughts and emotional responses related to pain.
- Algometry: The pain thresholds of the superficial masticatory muscles (masseter and temporalis) will be determined. Three measurements will be taken from the most prominent point of each muscle with the algometer applied perpendicularly to the skin. The highest value among the three will be recorded as the pain threshold for that muscle.
Jaw function will be another measured parameter, assessed using two different methods-one questionnaire and one physical evaluation.
- Jaw Functional Limitation Scale-20 (JFLS-20): This 20-item self-reported scale evaluates the functional limitations of the jaw and masticatory system. Higher scores indicate greater functional limitation.
- Orofacial Myofunctional Evaluation with Scores (OMES): This protocol includes multiple subcomponents that assess facial and temporomandibular function, appearance, and range of motion.
Tongue strength and endurance will be measured using the same device. Participants will be seated upright in a chair during the assessment. Tongue strength will be evaluated in two parts - anterior and posterior.
- For anterior tongue strength, the device bulb will be positioned on the palate just behind the upper front teeth, and the participant will be asked to press it with the tongue.
- For posterior tongue strength, the bulb will be placed on the posterior palate, and the participant will press it with the middle part of the tongue.
Three measurements will be taken, and the highest value will be recorded as the maximal tongue strength.
Quality of life will be evaluated using a self-administered questionnaire - the Oral Health Impact Profile (OHIP) - which assesses the perceived impact of oral health on daily life.
After completing all baseline assessments, participants will receive the assigned intervention according to their group allocation. Regardless of group assignment, all participants will be given home exercises, which include patient education about the joint, eating and drinking habits, and behavioral training. Diaphragmatic breathing exercises will be taught to promote relaxation of cervical muscles and proper breathing patterns. Posture exercises will be included to improve neck and back mechanics. Relaxation training will be provided to help reduce joint overactivity during stress. Participants will also be instructed on the appropriate use of thermal agents (hot and cold packs) when needed.
Myofunctional therapy will begin with cervical stretching, relaxation of paraspinal cervical muscles, and release techniques for the sternocleidomastoid and scalene muscles. Exercise intensity will be adjusted according to the patient's tolerance and tissue response. Massage techniques targeting the masticatory muscles and the temporal region will be applied to promote relaxation. Passive range of motion exercises will be performed to increase temporomandibular joint mobility.
Orofacial and tongue exercises aim to improve tongue mobility and include four-direction tongue mobilizations, resisted forward and upward tongue movements, safe mouth opening exercises, as well as cheek and lip exercises.
The intervention program will consist of 12 sessions conducted twice a week for 6 weeks, with each session lasting approximately 45 minutes. Every two weeks, tongue strength and endurance, pain thresholds (via algometry), and pain levels (via NPS) will be reassessed.
Adherence to home exercises will be monitored at each session. Participants' compliance with both supervised and home exercise programs will be recorded using exercise logs.
- Conditions
- TMD, TMD/Orofacial Pain
- Being tested
- Exercise, Manual therapy
- Keywords
- Orofacial Pain, TMD, Tongue Strength, OMES
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Orofacial exercises, TMD exercises
The orofacial and tongue exercises include four-directional tongue mobilizations and resisted tongue movements in forward and upward directions within the oral cavity to improve tongue mobility. In addition, safe mouth opening exercises, as well as cheek and lip exercises, are also included in the exercise program.
ExerciseOther
Also called Home Exercise
- Through in education program, participants will be informed about joint characteristics, eating and drinking habits, and behavioral training.
- Diaphragmatic breathing will be taught to promote relaxation of the cervical muscles and to establish a proper breathing pattern.
- Postural exercises will be instructed to improve neck and back mechanics.
- Relaxation training may help reduce joint activity that increases during periods of stress.
- When necessary, participants will also receive education on the appropriate use of hot and cold agents.
Manual therapyOther
Manual therapy will begin with cervical stretching, relaxation of the cervical paraspinal muscles, and release techniques for the sternocleidomastoid and scalene muscles.
The intensity of these exercises will be adjusted according to the patient's and tissue's tolerance.
Relaxation of the masticatory muscles will be achieved through massage applied externally to the jaw and the temporal region.
Passive range-of-motion exercises will be performed to increase the mobility of the temporomandibular joint.
| Study group | Role | What they receive |
|---|---|---|
| Orofacial Group | Experimental | The group planned to orofacial exercises and manual therapy intervention applying. Receives: Other: Exercise; Other: Manual therapy |
| Control Group | Active comparator | the group planned to manual therapy apply. Receives: Other: Exercise; Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
orofacial myofunctional evaluation with scores
The Orofacial Myofunctional Evaluation with Scores (OMES) protocol is designed to assess oral dysfunctions through multiple subdomains. These subdomains include appearance and posture, mobility, function, swallowing, mastication, functional occlusion, and mandibular movement. Higher scores indicate better functional status. The protocol has not yet been validated in Turkish. It was first used in a pediatric population and has also demonstrated validity in individuals with temporomandibular disorders.
Measured: From enrolment to the end of treatment at 6 weeks, in every two weeks
Secondary outcomes (2)
Pain threshold level of temporomandibular joint and temporal regions
Pain thresholds will be measured using an algometer. In this study, the measurement sites are the masseter muscle (2.5 cm anterior and 1.5 cm inferior to the tragus) and the temporalis muscle (3 cm above the lateral edge of the eye). During the measurement, the algometer will be held perpendicular to the skin. Measurements will be conducted in a quiet room. Each site will be measured three times with 30-second intervals between measurements, and the average of the three measurements will be used for analysis. The validity of algometric measurements has been previously established.
Measured: From enrollment to the end of treatment at 6 weeks, once every two weeks.
Pain Level of Numerical Pain Scale
The Numerical Pain Scale (NPS) is a self-reported or clinician-administered measurement tool that uses a numerical rating scale ranging from "no pain" to "worst possible pain". The scale is typically presented as a horizontal or vertical line and most commonly ranges from 0-10 or 0-100. It can be administered either in written or verbal form. Participants are asked to rate the intensity of their pain along this scale.
Measured: From enrollment to the end of treatment at 6 weeks, once in every two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start19 Jun 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMDStudies 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
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tayfun ISIK
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Tayfun ISIK, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304557
- Sponsor's protocol ID
- 0354
- Other IDs
- 0354
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding the sharing of individual participant data (IPD) has not yet been made. The plan for data sharing will be evaluated as the study progresses and upon obtaining the necessary ethics approvals.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF THE EFFECTS OF OROFACIAL AND TONGUE EXERCISES APPLIED AS AN ADDITION TO MYOFUNCTIONAL TREATMENT IN TEMPOROMANDIBULAR JOINT DISORDERS ON PAIN, JOINT AND TONGUE FUNCTIONS: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07304557
- Acronym / sponsor ID
- 0354
- Conditions
- TMD, TMD/Orofacial Pain
- Keywords
- Orofacial Pain, TMD, Tongue Strength, OMES
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Tayfun ISIKUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 26 Dec 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.
The goal of this clinical trial is to learn if orofacial exercises works to treat temporomandibular disorders in adults. It will also learn about the safety of orofacial exercises on temporomandibular disorders. The main questions it aims to answer are:
Does orofacial exercises improve function of temporomandibular disorders ? Does orofacial exercises decrease pain in temporomandibular disorders?
Researchers will compare orofacial exercises and manual therapy to manual therapy.
Participants will:
Take manual therapy and orofacial exercises or manual therapy two days in every week for 6 weeks Assessment once every 2 weeks for tests
Detailed description
The study will be conducted with two groups. While the control group will receive myofunctional therapy, the intervention group will receive orofacial and tongue exercises in addition to myofunctional therapy. The inclusion of orofacial and tongue exercises in the intervention group constitutes the main hypothesis of the study. The myofunctional therapy consists of home exercises, normal cervical joint movements, and massage techniques targeting the masticatory muscles.
At baseline, participants' eligibility for inclusion will be assessed. Individuals who meet the inclusion criteria will be randomly assigned to one of the two groups using a sealed envelope randomization method. Evaluation of participants will begin with the collection of demographic data. After recording the demographic information, further assessments will be conducted through questionnaires and instrumental measurements.
The first assessment will focus on pain evaluation, using three different methods.
- Numerical Pain Scale (NPS): This scale assesses pain intensity in three different conditions - during chewing, at rest, and during sleep. Participants will rate their pain on a scale from "0" (no pain) to "10" (worst imaginable pain).
- Pain Catastrophizing Scale (PCS): This self-administered questionnaire evaluates the participant's thoughts and emotional responses related to pain.
- Algometry: The pain thresholds of the superficial masticatory muscles (masseter and temporalis) will be determined. Three measurements will be taken from the most prominent point of each muscle with the algometer applied perpendicularly to the skin. The highest value among the three will be recorded as the pain threshold for that muscle.
Jaw function will be another measured parameter, assessed using two different methods-one questionnaire and one physical evaluation.
- Jaw Functional Limitation Scale-20 (JFLS-20): This 20-item self-reported scale evaluates the functional limitations of the jaw and masticatory system. Higher scores indicate greater functional limitation.
- Orofacial Myofunctional Evaluation with Scores (OMES): This protocol includes multiple subcomponents that assess facial and temporomandibular function, appearance, and range of motion.
Tongue strength and endurance will be measured using the same device. Participants will be seated upright in a chair during the assessment. Tongue strength will be evaluated in two parts - anterior and posterior.
- For anterior tongue strength, the device bulb will be positioned on the palate just behind the upper front teeth, and the participant will be asked to press it with the tongue.
- For posterior tongue strength, the bulb will be placed on the posterior palate, and the participant will press it with the middle part of the tongue.
Three measurements will be taken, and the highest value will be recorded as the maximal tongue strength.
Quality of life will be evaluated using a self-administered questionnaire - the Oral Health Impact Profile (OHIP) - which assesses the perceived impact of oral health on daily life.
After completing all baseline assessments, participants will receive the assigned intervention according to their group allocation. Regardless of group assignment, all participants will be given home exercises, which include patient education about the joint, eating and drinking habits, and behavioral training. Diaphragmatic breathing exercises will be taught to promote relaxation of cervical muscles and proper breathing patterns. Posture exercises will be included to improve neck and back mechanics. Relaxation training will be provided to help reduce joint overactivity during stress. Participants will also be instructed on the appropriate use of thermal agents (hot and cold packs) when needed.
Myofunctional therapy will begin with cervical stretching, relaxation of paraspinal cervical muscles, and release techniques for the sternocleidomastoid and scalene muscles. Exercise intensity will be adjusted according to the patient's tolerance and tissue response. Massage techniques targeting the masticatory muscles and the temporal region will be applied to promote relaxation. Passive range of motion exercises will be performed to increase temporomandibular joint mobility.
Orofacial and tongue exercises aim to improve tongue mobility and include four-direction tongue mobilizations, resisted forward and upward tongue movements, safe mouth opening exercises, as well as cheek and lip exercises.
The intervention program will consist of 12 sessions conducted twice a week for 6 weeks, with each session lasting approximately 45 minutes. Every two weeks, tongue strength and endurance, pain thresholds (via algometry), and pain levels (via NPS) will be reassessed.
Adherence to home exercises will be monitored at each session. Participants' compliance with both supervised and home exercise programs will be recorded using exercise logs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orofacial Group | Experimental | Other: Exercise, Other: Manual therapyThe group planned to orofacial exercises and manual therapy intervention applying. |
| Control Group | Active comparator | Other: Exercise, Other: Manual therapythe group planned to manual therapy apply. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 - 65 aged people
- Not having received physical therapy for the neck or jaw within the past three months.
- No history of surgical or oncological treatment related to the neck or jaw.
- Having a diagnosis of temporomandibular disorder according to the RDC/TMD criteria, specifically Group Ia, Group Ib, or Group IIa under Axis I.
Key exclusion criteria (3 listed)
- Individuals who are pregnant or suspected to be pregnant.
- Individuals with rheumatologic diseases affecting the temporomandibular joint.
- Individuals with a diagnosed psychiatric disorder.
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 |
|---|---|---|
| ExerciseAlso: Orofacial exercises, TMD exercisesThe orofacial and tongue exercises include four-directional tongue mobilizations and resisted tongue movements in forward and upward directions within the oral cavity to improve tongue mobility. In addition, safe mouth opening exercises, as well as cheek and lip exercises, are also included in the exercise program. | Other | Orofacial Group |
| ExerciseAlso: Home Exercise* Through in education program, participants will be informed about joint characteristics, eating and drinking habits, and behavioral training. * Diaphragmatic breathing will be taught to promote relaxation of the cervical muscles and to establish a proper breathing pattern. * Postural exercises will be instructed to improve neck and back mechanics. * Relaxation training may help reduce joint activity that increases during periods of stress. * When necessary, participants will also receive education on the appropriate use of hot and cold agents. | Other | Control Group, Orofacial Group |
| Manual therapyManual therapy will begin with cervical stretching, relaxation of the cervical paraspinal muscles, and release techniques for the sternocleidomastoid and scalene muscles. The intensity of these exercises will be adjusted according to the patient's and tissue's tolerance. Relaxation of the masticatory muscles will be achieved through massage applied externally to the jaw and the temporal region. Passive range-of-motion exercises will be performed to increase the mobility of the temporomandibular joint. | Other | Control Group, Orofacial Group |
Primary outcome
orofacial myofunctional evaluation with scores
Time frame: From enrolment to the end of treatment at 6 weeks, in every two weeks
The Orofacial Myofunctional Evaluation with Scores (OMES) protocol is designed to assess oral dysfunctions through multiple subdomains. These subdomains include appearance and posture, mobility, function, swallowing, mastication, functional occlusion, and mandibular movement. Higher scores indicate better functional status. The protocol has not yet been validated in Turkish. It was first used in a pediatric population and has also demonstrated validity in individuals with temporomandibular disorders.
2 secondary outcomes
Pain threshold level of temporomandibular joint and temporal regions
Time frame: From enrollment to the end of treatment at 6 weeks, once every two weeks.
Pain Level of Numerical Pain Scale
Time frame: From enrollment to the end of treatment at 6 weeks, once in every two 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 26 Dec 2025.
- Individual participant dataSharing planned: Undecided. A decision regarding the sharing of individual participant data (IPD) has not yet been made. The plan for data sharing will be evaluated as the study progresses and upon obtaining the necessary ethics approvals.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Manual therapy in people with TMD and TMD/Orofacial Pain, run by Tayfun ISIK 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 26 Dec 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?
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 Tayfun ISIK, MSc (+90 506 688 19 14, tayfisik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
orofacial myofunctional evaluation with scores (time frame: From enrolment to the end of treatment at 6 weeks, in every two weeks). 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 26 Dec 2025.