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AzTrials

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).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Tayfun ISIK, MSc contact

+90 506 688 19 14

tayfisik@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Ankara Medipol University

    Ankara, ALTINDAG

    Gulcan HARPUT, PROF. DR., +90 541 788 33 23, aktasgulcan@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

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.

  1. 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).
  2. Pain Catastrophizing Scale (PCS): This self-administered questionnaire evaluates the participant's thoughts and emotional responses related to pain.
  3. 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.

  1. 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.
  2. 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.

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 groups in NCT07304557
Study groupRoleWhat they receive
Orofacial GroupExperimentalThe group planned to orofacial exercises and manual therapy intervention applying.
Receives: Other: Exercise; Other: Manual therapy
Control GroupActive comparatorthe 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.

  1. 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)
  1. 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.

  2. 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.

  1. First posted26 Dec 2025
  2. Study start19 Jun 2025
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion15 Nov 2026 (estimated)

Resources

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)
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.

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.

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