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Temporomandibular Joint DisordersNCT05607823

Adding Core Stabilization Training to Manuel Therapy in Temporomandibular Joint Disorders

A study testing Core Stabilization Training, Orofacial Manual Therapy and Conventional Physiotherapy in people with Temporomandibular Joint Disorders, run by Marmara University 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
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Trial summary

This study aims to compare the effectiveness of three different treatment approaches in individuals with DDwR symptoms. It is hypothesized that adding core stabilization training (CST) to orofacial manual therapy (OMT) will enhance treatment outcomes. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Temporomandibular Joint Disorders
What is being tested?
Core Stabilization Training, Orofacial Manual Therapy and Conventional Physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Nov 2022to 10 Feb 2024
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Volunteered to participate,
  • Aged between 18-60 years old,
  • Having the diagnosis of Temporomandibular Disorders (TMD) - Reduction Disc Displacement (DDwR)

Who cannot join

  • Having a malignant condition, trauma and surgery of the cranial and cervical region,
  • Not being cooperative,
  • Regular use of analgesic and anti-inflammatory drugs,
  • Having dentofacial anomalies,
  • Having active arthritis,
  • Having lumbal pathology,
Show all 10Show fewer
  • Having metabolic diseases,
  • Having connective tissue, rheumatological and hematological disorders,
  • Having a diagnosed psychiatric illness,
  • Receiving TMD-related physical therapy less than 6 months ago

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Sultan İğrek

    Istanbul, 34275

Other trials in Turkey (Türkiye)

About this study

Official title: Adding Core Stabilization Training to Orofacial Manuel Therapy in Individuals With Temporomandibular Joint Disc Displacement With Reduction: A Randomized Controlled Study

This study aims to compare the effectiveness of three different treatment approaches in individuals with DDwR symptoms. It is hypothesized that adding core stabilization training (CST) to orofacial manual therapy (OMT) will enhance treatment outcomes. Patients will be treated for 10 sessions once a week, for a total of 10 weeks. Evaluation was planned to be done twice, at the beginning and end of the treatment.

Read the detailed description

This study aims to compare the effectiveness of three different treatment approaches in individuals with DDwR symptoms. It is hypothesized that adding core stabilization training (CST) to orofacial manual therapy (OMT) will enhance treatment outcomes. The patients to be included in the study will be randomly divided into three groups and it is planned to include 15 people in each group. Home exercises and patient education will be provided to all patients.

  • Group 1 (CST group): Orofacial manual therapy + core stabilization training (CST) + home exercise and patient education
  • Group 2 (OMT group): Orofacial manual therapy (OMT) + home exercise and patient education
  • Group 3 (Control group): Home exercise and patient education.

Pain intensity, pressure pain threshold, joint range of motion, posture, flexibility, stabilization of core muscles, functionality and sleep quality will be evaluated by using Numeric Pain Scale (NPS), digital algometer, ruler, Palpation Meter (PALM), bubble inclinometer, tape measure, Finger-to-floor distance (EPZM) and sit-reach test, pressure biofeedback unit, "Helkimo Index", "Pittsburgh Sleep Quality Index (PUKI)" respectively. Patients will be treated for 10 sessions once a week, for a total of 10 weeks. Evaluation was planned to be done twice, at the beginning and end of the treatment.

Being tested
Core Stabilization Training, Orofacial Manual Therapy, Conventional Physiotherapy
Keywords
core stability, exercise, Temporomandibular joint disorders, facial pain, comprehensive health care
Medical subject headings
Temporomandibular Joint Disorders, Motor Activity, Facial Pain

What participants receive

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

  • Core Stabilization TrainingOther

    Core Stabilization training will be based on dynamic neuromuscular stabilization and consists of three stages. In the first session, it is to teach the simultaneous activation of the transversus abdominis, pelvic floor, multifidus and diaphragm muscles and to improve muscle coordination and proprioception in the entire spinal region. In the second and third phases, exercises will be made more intense to improve muscular endurance and stability. The difficulty of the exercises will be increased by working in different positions, using resistance bands, exercise balls and body weight, and adding movements to the extremities. A total of 10 sessions of treatment program will be applied to the patients for ten weeks, once a week.

  • Orofacial Manual TherapyOther

    As orofacial manual therapy, soft tissue (intraoral and extraoral trigger point therapy and myofascial release of painful muscles) and joint mobilization (caudal and ventro-caudal traction, ventral and mediolateral translation), muscle energy technique, fascia mandibularis release, occipital release and ligamentous treatment was planned.

  • Conventional PhysiotherapyOther

    Conventional physiotherapy consists of home exercise and patient education. Patient education consists of parafunctional behaviors, habits, a diet with soft food, and posture education. The exercises consist of exercises for the mandible, cervical and thoracic region and breathing. All movements are planned to be done at home 3 times a day, every day of the week.

Study groups in NCT05607823
Study groupRoleWhat they receive
CST GroupExperimentalThe core stabilization group. Participants in this group will be received core stabilization training, orofacial manuel therapy and conventional physiotherapy (Home exercise program and patient education) as treatment. The number of participants is planned to be 15.
Receives: Other: Core Stabilization Training; Other: Orofacial Manual Therapy; Other: Conventional Physiotherapy
OMT GroupExperimentalThe orofacial manuel therapy group. Participants in this group will be received orofacial manuel therapy and conventional physiotherapy (Home exercise program and patient education) as treatment. The number of participants is planned to be 15.
Receives: Other: Orofacial Manual Therapy; Other: Conventional Physiotherapy
Control GroupExperimentalParticipants in this group will be received only conventional physiotherapy (Home exercise program and patient education) as treatment. The number of participants is planned to be 15.
Receives: Other: Conventional Physiotherapy

What is being measured

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

  1. Pain severity: VAS

    The severity of pain in the orofacial region was evaluated using a Numeric Pain Scale (NPS). The patients were instructed to mark the level of pain felt during rest, clenching and maximum mouth opening on a 10-cm line ranging from 0 (no pain) to 10 (intolerable pain).

    Measured: Change from Baseline pain severity at 10 weeks.

  2. Pain Threshold: Digital algometer

    The algometer is a reliable instrument for measuring the sensitivity of the masticatory muscles. The measurement will be made at 8 points. A force (Newton in force) of 1 kg (weight in kilogram) per square centimeter (surface area in centimeter square) is applied to the patient for 3 seconds, and this is continued until the patient feels pain (weight and surface area will be combined to report Newton in kg/ cm2). The physiotherapist will passively support the individual's head with the other hand. This process will be repeated three times and the average value will be calculated.

    Measured: Change from Baseline pain threshold at 10 weeks.

  3. Range of Motion

    Mouth opening, protrusion and right and left lateral deviation will be measured starting from 0 using a 15 cm ruler. Repeated measuring reduces the standard error of measurement, hence repeated measurements were also included in our study (three times) with the largest recorded range taken.

    Measured: Change from Baseline range of motion at 10 weeks.

  4. Facial asymmetry

    For facial asymmetry evaluation, the distance between the anterior notch of the chin and the mandible line will be measured with a tape measure.

    Measured: Change from Baseline facial asymmetry at 10 weeks.

  5. Degree of pelvic tilt

    Palpation Meter (PALM), (Salt Lake City, United Kingdom, USA) will be used for pelvic tilt evaluation. The Palpation Meter has an angle inclinometer and two 360-swivel arms, one of arms will be placed in the Spina iliaca Anterior Superior (SIAS) and the other in the Spina iliaca Posterior Superior (SIPS). In this position, the angle indicated by the inclinometer will be recorded as the pelvic tilt angle.

    Measured: Change from Baseline degree of pelvic tilt at 10 weeks.

  6. Degree of lordosis

    Bubble inclinometer (White Plains, New York 10602 USA) will be used for lumbar lordosis evaluation. The degree of lordosis will be determined by measuring the spinous processes of the T12-L1 and S2-3 vertebrae with a bubble inclinometer and adding the degrees found.

    Measured: Change from Baseline degree of lordosis at 10 weeks.

Secondary outcomes (5)

  1. Flexibility of lumbal extensor muscles

    Finger-to-floor distance (EPZM) will be used for flexibility of lumbal extensor. In the EPZM test, individuals will stand on a stool and are asked to bend their torso forward to reach as far as possible with both hands without bending the knees. The distance between the stool level and the middle finger will be measured by the therapist and and this distance will be recorded in cm. The individual will be asked to repeat this movement three times and the highest value will be taken as the test score.

    Measured: Change from Baseline Finger-to-floor distance (EPZM) at 10 weeks.

  2. Flexibility of hamstring muscles

    Sit-reach test will be used for flexibility of hamstring muscles. For the sit-and-reach test, the individual will be seated without shoes in a long sitting position on the floor, with his feet propped on a 30 cm bench that is scaled by dividing the top into cm. The body will be asked to lie forward on the coffee table as much as possible without bending the knees, wait 2 seconds at the extreme point where the fingers are extended, and this distance will be recorded in cm. The individual will be asked to repeat this movement three times and the highest value will be taken as the test score.

    Measured: Change from Baseline sit-reach test at 10 weeks.

  3. Performance of stabilizer muscles

    Lumbopelvic stabilization will be assessed using a pressure biofeedback unit (Stabilizer Pressure Biofeedback Unit, Chattanooga Group Inc., Hixson, Tennessee, USA). Individuals will be asked to lie on their back in a hooked position. The pressure cell of the instrument will be placed under the lumbar vertebrae. The subjects will be asked to perform the abdominal drawing-in maneuver as previously taught, with no spinal or pelvic movement. The change in pressure will be recorded in mmHg and the time that the contraction can be maintained in seconds.

    Measured: Change from Baseline lumbopelvic stabilization at 10 weeks.

  4. Functionality

    "Helkimo Index" will be used to evaluate Temporomandibular Joint (TMJ) pain and dysfunction. This index evaluates the clinical dysfunction of the stomatognathic system based on the 5 signs of TMD. Pain during mandible movement, TMJ pain, pain in masticatory muscles, TMJ sound and maximum mouth opening are evaluated with different questions between 0-5. The total dysfunction score ranges from 0 to 25. 0 no dysfunction; Values 1-4 are mild dysfunction; Values from 4 to 9 indicate moderate dysfunction; Values above 9 indicate severe dysfunction.

    Measured: Change from Baseline Helkimo Index at 10 weeks.

  5. Sleep

    "Pittsburgh Sleep Quality Index (PUKI)" will be used to assess sleep quality and impairment. It consists of 7 subscales that assess subjective sleep quality, sleep latency and duration, habitual sleep efficiency, sleep disorders, use of sleep medication, and loss of daytime functionality. A high total score indicates poor sleep quality.

    Measured: Change from Baseline Pittsburgh Sleep Quality Index (PUKI) at 10 weeks.

Timeline

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

  1. First posted7 Nov 2022
  2. Study start6 Nov 2022
  3. Primary completion1 Nov 2023
  4. Study completion10 Feb 2024

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
Factorial
Model description
There are three study groups: 1.CST group: Participants in this group will be received core stabilization training, orofacial manuel therapy and conventional physiotherapy (Home exercise program and patient education). 2. OMT group: Participants in this group will be received orofacial manuel therapy and conventional physiotherapy (Home exercise program and patient education) as treatment. 3. Control Group: Participants in this group received only conventional physiotherapy (Home exercise program and patient education) as treatment.
Masking
Single blind
Who is masked
Participant
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05607823
Sponsor's protocol ID
09.2022.951
Status last verified
Oct 2022
First submitted
22 Oct 2022
Last updated
27 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) might be considered to be shared with clinicians studying in the same field one year after the publication of the study.

Publications

  • Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.

    PubMed 15928561

  • Liu F, Steinkeler A. Epidemiology, diagnosis, and treatment of temporomandibular disorders. Dent Clin North Am. 2013 Jul;57(3):465-79. doi: 10.1016/j.cden.2013.04.006.

    PubMed 23809304

  • Anastassaki Kohler A, Hugoson A, Magnusson T. Prevalence of symptoms indicative of temporomandibular disorders in adults: cross-sectional epidemiological investigations covering two decades. Acta Odontol Scand. 2012 May;70(3):213-23. doi: 10.3109/00016357.2011.634832. Epub 2011 Nov 30.

    PubMed 22126531

  • Nekora-Azak A, Evlioglu G, Ordulu M, Issever H. Prevalence of symptoms associated with temporomandibular disorders in a Turkish population. J Oral Rehabil. 2006 Feb;33(2):81-4. doi: 10.1111/j.1365-2842.2006.01543.x.

    PubMed 16457666

  • Hoffmann RG, Kotchen JM, Kotchen TA, Cowley T, Dasgupta M, Cowley AW Jr. Temporomandibular disorders and associated clinical comorbidities. Clin J Pain. 2011 Mar-Apr;27(3):268-74. doi: 10.1097/AJP.0b013e31820215f5.

    PubMed 21178593

  • Lee KC, Wu YT, Chien WC, Chung CH, Chen LC, Shieh YS. The prevalence of first-onset temporomandibular disorder in low back pain and associated risk factors: A nationwide population-based cohort study with a 15-year follow-up. Medicine (Baltimore). 2020 Jan;99(3):e18686. doi: 10.1097/MD.0000000000018686.

    PubMed 32011444

  • Cuccia A, Caradonna C. The relationship between the stomatognathic system and body posture. Clinics (Sao Paulo). 2009;64(1):61-6. doi: 10.1590/s1807-59322009000100011.

    PubMed 19142553

  • Gangloff P, Louis JP, Perrin PP. Dental occlusion modifies gaze and posture stabilization in human subjects. Neurosci Lett. 2000 Nov 3;293(3):203-6. doi: 10.1016/s0304-3940(00)01528-7.

    PubMed 11036196

  • Espinosa de Santillana IA, Garcia-Juarez A, Rebollo-Vazquez J, Ustaran-Aquino AK. [Frequent postural alterations in patients with different types of temporomandibular disorders]. Rev Salud Publica (Bogota). 2018 May-Jun;20(3):384-389. doi: 10.15446/rsap.V20n3.53529. Spanish.

    PubMed 30844014

  • Saito ET, Akashi PM, Sacco Ide C. Global body posture evaluation in patients with temporomandibular joint disorder. Clinics (Sao Paulo). 2009;64(1):35-9. doi: 10.1590/s1807-59322009000100007.

    PubMed 19142549

  • Fischer MJ, Riedlinger K, Gutenbrunner C, Bernateck M. Influence of the temporomandibular joint on range of motion of the hip joint in patients with complex regional pain syndrome. J Manipulative Physiol Ther. 2009 Jun;32(5):364-71. doi: 10.1016/j.jmpt.2009.04.003.

    PubMed 19539119

  • Fink M, Wahling K, Stiesch-Scholz M, Tschernitschek H. The functional relationship between the craniomandibular system, cervical spine, and the sacroiliac joint: a preliminary investigation. Cranio. 2003 Jul;21(3):202-8. doi: 10.1080/08869634.2003.11746252.

    PubMed 12889677

  • de Oliveira-Souza AIS, de O Ferro JK, Barros MMMB, Oliveira DA. Cervical musculoskeletal disorders in patients with temporomandibular dysfunction: A systematic review and meta-analysis. J Bodyw Mov Ther. 2020 Oct;24(4):84-101. doi: 10.1016/j.jbmt.2020.05.001. Epub 2020 May 11.

    PubMed 33218570

  • von Piekartz H, Hall T. Orofacial manual therapy improves cervical movement impairment associated with headache and features of temporomandibular dysfunction: a randomized controlled trial. Man Ther. 2013 Aug;18(4):345-50. doi: 10.1016/j.math.2012.12.005. Epub 2013 Feb 14.

    PubMed 23415640

  • Wright EF, Domenech MA, Fischer JR Jr. Usefulness of posture training for patients with temporomandibular disorders. J Am Dent Assoc. 2000 Feb;131(2):202-10. doi: 10.14219/jada.archive.2000.0148.

    PubMed 10680388

Questions about this trial

What is this clinical trial studying?

A study testing Core Stabilization Training, Orofacial Manual Therapy and Conventional Physiotherapy in people with Temporomandibular Joint Disorders, run by Marmara 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 3 inclusion and 10 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 27 Aug 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?

Pain severity: VAS (time frame: Change from Baseline pain severity at 10 weeks.). 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?

On the ClinicalTrials.gov record for NCT05607823, which also lists 31 linked publications.

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 27 Aug 2025.

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