AzTrials
AzTrials

Temporomandibular Joint DysfunctionNCT06883825

Temporomandibular Joint Respiratory and Thoracic Region Added to Myofunctional Rehabilitation in Dysfunction Comparison of the Effects of Exercises

A study testing Myofunctional Therapy, Myofunctional Therapy + Respiratory Exercises and Myofunctional Therapy + Thoracic Region Exercises in people with Temporomandibular Joint Dysfunction and Myofunctional Therapy, run by Merve Keskin at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In the study, a questionnaire form will be applied to the participants using a face-to-face interview technique. Through the questionnaires, demographic characteristics, pain intensity, location of pain, symptoms of dysfunction, oral habits, and loss of function in the jaw joint will be evaluated. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Myofunctional Therapy, Myofunctional Therapy + Respiratory Exercises and Myofunctional Therapy + Thoracic Region Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteTurkey (Türkiye)
Study dates
16 Oct 2024to 30 Jun 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

  • 18-65 years old,
  • According to the Temporomandibular Disorders Research Diagnostic Criteria;
  • With muscle involvement,
  • With muscle+joint involvement
  • Those who volunteer to participate in the study will be included

Who cannot join

  • According to the Temporomandibular Disorders Research Diagnostic Criteria;
  • Those with disc displacement without reduction,
  • Those with arthritis
  • Those with a known neurological, systemic or psychological disease,
  • Pregnant and lactating women,
  • Those who have had any trauma/surgical operation in the last 6 months,
Show all 9Show fewer
  • Those with severe to severe local and/or general musculoskeletal pain,
  • Patients with an obstructive or restrictive respiratory problem,
  • Those with scoliosis that may cause respiratory problems will not be included

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Izmir Katip Celebi University

    Çiğli, İzmir, 35620

Other trials in Turkey (Türkiye)

About this study

Official title: Temporomandibular Joint Respiratory and Thoracic Region Added to Myofunctional Rehabilitation in Dysfunction Comparison of the Effects of Exercises: A Randomized Controlled Trial

In the study, a questionnaire form will be applied to the participants using a face-to-face interview technique. Through the questionnaires, demographic characteristics, pain intensity, location of pain, symptoms of dysfunction, oral habits, and loss of function in the jaw joint will be evaluated. Soft tissue (muscle) affections, spine structure, and mobility will be evaluated and recorded in the questionnaire form to be used for the evaluation of jaw joint dysfunctions. Pain level, depression, stress, anxiety level, and sleep quality will be evaluated with the help of a questionnaire.

The aims of this study were;

Read more
  1. To investigate the effects of muscle and function therapy on dysfunction, spinal structure and mobility, depression, stress, anxiety, and sleep quality in patients with jaw joint dysfunction,
  2. To investigate the effects of breathing exercises added to muscle and function therapy on dysfunction, spine structure and mobility, depression, stress, anxiety, and sleep quality in patients with jaw joint dysfunction,
  3. To investigate the effects of back exercises added to muscle and function therapy on dysfunction, spinal structure and mobility, depression, stress, anxiety and sleep quality in patients with jaw joint dysfunction,
  4. To compare the effects of muscular and functional therapy alone, respiratory exercises added to muscular and functional therapy, and back exercises on dysfunction, spinal structure and mobility, depression, stress, anxiety, and sleep quality in patients with jaw joint dysfunction.

Hypotheses of this study; H1: Myofunctional rehabilitation in patients with temporomandibular joint dysfunction positively affects TMD dysfunction findings, spinal structure and mobility, and psychosocial effects.

H2: Respiratory exercises added to myofunctional rehabilitation in patients with temporomandibular joint dysfunction have a positive effect on TMD dysfunction findings, spinal structure and mobility, and psychosocial effects.

H3: Thoracic exercises added to myofunctional rehabilitation in patients with temporomandibular joint dysfunction have a positive effect on TMD dysfunction findings, spinal structure, mobility, and psychosocial effects.

H4: In patients with temporomandibular joint dysfunction, only myofunctional rehabilitation, respiratory exercises added to myofunctional rehabilitation, and thoracic exercises have no superiority over each other on TMD dysfunction symptoms, spinal structure mobility, and psychosocial effects.

In the study, a questionnaire form will be applied to the participants usinga face-to-face interview. Through the questionnaires, demographic characteristics, pain intensity, pain location, symptoms of dysfunction, oral habits, and the presence of jaw joint dysfunctions will be evaluated. Soft tissue (muscle) affections, spine structure, and mobility will be assessed and recorded in the questionnaire form to be used for the evaluation of jaw joint dysfunctions. Pain level, depression, stress, anxiety level, and sleep quality will be evaluated with the help of a questionnaire. The evaluation will take approximately 40-45 minutes.

Group 1 will be given a massage to relax the masticatory muscles and exercises for the masticatory muscles and the muscles in the neck region.

The 2nd group will be given breathing exercises in addition to the 1st group. The 3rd group will be given back exercises in addition to the 1st group. One session will last approximately 45-50 minutes, and a total of 16 sessions of treatment will be applied in 8 weeks, 2 sessions per week. Measurements will be taken twice, at the beginning and the end of the 8th week.

Read the detailed description

This research is planned as a randomized controlled study. The study will be conducted at Izmir Kâtip Çelebi University within two years after ethics committee permission is obtained. The population of the study consists of patients with temporomandibular joint dysfunction. The sample of our study will consist of patients aged 18-65 years with muscle and joint involvement according to the Temporomandibular Disorders Research Diagnostic Criteria, who volunteered to participate in the study. No suitable article using similar methods for calculating the sample size of the study was found. According to the power analysis for two-way analysis of variance in repeated measures using G*Power Version 3.1.9.2 (Franz Faul, Universitat Kiel, Germany) program, the effect size was calculated as f=0.5, number of repetitions=2, number of groups=3, correlation between repeated measures =0.5, Type I error=0.05 and statistical power=0.95, with at least 17 in each group and a total of 51 patients as the number of units in the sample. Considering possible data losses, the number of participants was added by 20% and it was planned to include at least 21 patients in a group and 63 patients in total.

Participants will be divided into three groups as myofunctional rehabilitation group, respiratory exercise group, and thoracic exercise group by block randomization method. Block randomization will be done via https://www.sealedenvelope.com/simple-randomiser/v1/lists.

1st group; deep friction massage to trigger points in masseter and temporalis muscles, mobilization to TMJ and surrounding soft tissues, Rocabodo exercises (6x6), suboccipital relaxation, stretching exercises to upper trapezius, pectoralis minor, levator scapula muscles will be applied.

Group 2 will be given progressive diaphragmatic breathing exercises in addition to group 1. Progression in diaphragmatic breathing exercises will be achieved by adapting the phases of sensorimotor training (static, dynamic, functional) adapted to exercise programs in order to prevent injuries and to ensure strength and stability (15,16).

Diaphragmatic exercises

  1. Static Phase (weeks 1-2): It is aimed to provide short-speed motor control and to create kinesthetic awareness. It will include exercises to provide diaphragmatic breathing at each stage of neurodevelopmental steps (supine, side lying, quadripedal, bipedal).
  2. Dynamic Phase (weeks 3-5): Following the teaching of diaphragmatic breathing at each stage of neurodevelopmental steps, limb movements will be included in the program with elastic resistance training. In order to teach conscious motor control of movement, they will be asked to maintain diaphragmatic breathing while performing coordinated limb movements at high speeds in a multi-planar field.

3rd Functional Phase (weeks 6-8): After the combination of diaphragmatic breathing with limb movements, exercises including functional complex training on unstable floors will take place in this phase in order to teach the subconscious control of the movement with the progressive resistances of elastic resistance training. For this purpose, elastic resistance bands and exercise balls will be used.

Diaphragmatic breathing exercises will consist of 3 sets of 10 repetitions in each session.

The 3rd group will be given progressive thoracic exercises in addition to the 1st group. Thoracic exercises will consist of 6 exercises including thoracic stretching and mobility exercises lasting 15-20 minutes. Progression in the program will be achieved by changing the color of the elastic resistance band used during the exercises and gradually increasing the number of repetitions of the exercises. To determine the resistance of the elastic resistance band, the participant will be asked to perform the determined movement for 15 repetitions. If the participant's fatigue is at the level of 12-14 (moderate difficulty) according to the Borg scale, which is a subjective questioning tool, it will indicate the appropriate color. Elastic resistance bands are ordered from easy level to more difficult level with skin, yellow, red, green, blue, black, gray, and golden yellow colors.

Exercises for the thoracic region;

  1. Thoracic spine extension exercise with a foam roller (2x10),
  2. Thoracic extension flexibility exercise (2x10),
  3. Thoracic spine rotation exercise (2x8),
  4. Thoracic rotation exercise in quadripedal position (2x8),
  5. Thoracic rotation exercise in side lying (Open book 2x8),
  6. Bird-dog exercise (2x8). One session will last approximately 45-50 minutes, 2 sessions per week, for a total of 16 sessions in 8 weeks. Measurements will be taken twice, at the beginning and the end of the 8th week.
Being tested
Myofunctional Therapy, Myofunctional Therapy + Respiratory Exercises, Myofunctional Therapy + Thoracic Region Exercises
Keywords
temporomandibular joint dysfunction, myofunctional therapy, rehabilitation, exercise, thoracic region, diapragmatic breathing
Medical subject headings
Temporomandibular Joint Disorders, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Myofunctional TherapyOther

    Participants will only receive myofunctional rehabilitation therapy. This treatment includes massage and exercises to improve the function of the jaw muscles.

  • Myofunctional Therapy + Respiratory ExercisesOther

    Participants will receive breathing exercises as well as myofunctional therapy. This treatment includes exercises to improve jaw function and support the respiratory system.

  • Myofunctional Therapy + Thoracic Region ExercisesOther

    Participants will receive myofunctional therapy as well as exercises for the thoracic region. This treatment includes exercises to improve jaw function and increase the flexibility of the chest area.

Study groups in NCT06883825
Study groupRoleWhat they receive
Myofunctional TherapyActive comparatorParticipants will only receive myofunctional rehabilitation therapy. This treatment includes massage and exercises to improve the function of the jaw muscles.
Receives: Other: Myofunctional Therapy
Myofunctional Therapy + Respiratory ExercisesExperimentalParticipants will receive breathing exercises as well as myofunctional therapy. This treatment includes exercises to improve jaw function and support the respiratory system.
Receives: Other: Myofunctional Therapy + Respiratory Exercises
Myofunctional Therapy + Thoracic Region ExercisesExperimentalParticipants will receive myofunctional therapy as well as exercises for the thoracic region. This treatment includes exercises to improve jaw function and increase the flexibility of the chest area.
Receives: Other: Myofunctional Therapy + Thoracic Region Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of Temporomandibular Joint Dysfunction

    Diagnosis of TMD - Evaluated using the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), reported as categorical data (diagnosis classification).

    Measured: At baseline and from enrollment to the end of treatment at week 8

  2. Pain Assessment

    Measured using the Visual Analog Scale (VAS), reported in centimeters (cm)

    Measured: At baseline and from enrollment to the end of treatment at week 8

  3. Symptom Severity

    Assessed with the Symptom Questionnaire for Temporomandibular Disorders, reported in units on a scale.

    Measured: At baseline and from enrollment to the end of treatment at week 8

  4. Oral Habits Frequency

    Measured with the Oral Habits Checklist, reported in units on a scale.

    Measured: At baseline and from enrollment to the end of treatment at week 8

  5. Jaw Function Limitation

    Assessed using the Jaw Function Restriction Scale, reported in units on a scale.

    Measured: At baseline and from enrollment to the end of treatment at week 8

  6. Soft Tissue Examination

    Assessed using ultrasound to measure masseter muscle thickness and elastography at rest and during contraction, reported in millimeters (mm) and kilopascals (kPa), respectively.

    Measured: At baseline and from enrollment to the end of treatment at week 8

Secondary outcomes (5)
  1. Head Position

    Measured as the angle between the head and neck, recorded in degrees (°).

    Measured: At baseline and from enrollment to the end of treatment at week 8

  2. Thoracic Region Evaluation

    Assessed using the Valedo Shape device, with angular measurements recorded in degrees (°).

    Measured: At baseline and from enrollment to the end of treatment at week 8

  3. Thoracic Rotation

    Measured using a mobile application, recorded in degrees (°).

    Measured: At baseline and from enrollment to the end of treatment at week 8

  4. Depression, Anxiety, and Stress

    Assessed using the DASS-21 questionnaire, reported in units on a scale.

    Measured: At baseline and from enrollment to the end of treatment at week 8

  5. Sleep Quality

    Evaluated using a single-item sleep quality scale, reported in units on a scale.

    Measured: At baseline and from enrollment to the end of treatment at week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2025
  2. Study start16 Oct 2024
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

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
Single blind
Who is masked
Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06883825
Sponsor's protocol ID
0090
Status last verified
Feb 2025
First submitted
24 Feb 2025
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Myofunctional Therapy, Myofunctional Therapy + Respiratory Exercises and Myofunctional Therapy + Thoracic Region Exercises in people with Temporomandibular Joint Dysfunction and Myofunctional Therapy, run by Merve Keskin 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 5 inclusion and 9 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 13 Jan 2026. 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?

Evaluation of Temporomandibular Joint Dysfunction (time frame: At baseline and from enrollment to the end of treatment at week 8). The study lists 6 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 13 Jan 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in