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Completed

NCT Number: NCT05599113

Can Extracorporeal Shock Wave Therapy Be Effective in Temporomandibular Joint Disease

The aim of this study is to evaluate the clinical efficacy of Extracorporeal Shock Wave Therapy (ESWT) in patients with Temporomandibular Joint (TMJ) with Reduced Disc Displacement, by comparing it with standard treatment.

Scientific Basis and Validity of Medical Research: Temporomandibular Joint Disorders (TMR) are disorders that can cause pain in the head and neck region, limitation in mouth opening, and difficulties even in daily activities (eating, speaking, chewing, yawning, etc.). These disorders have various causes such as malocclusion, emotional stress, parafunctional habits, synovitis, capsulitis, osteoarthritis and intra-articular irregularities. Almost 25% of the world's population has TMJ intra-articular irregularities and these are usually treated with non-surgical methods. If these methods are not successful, surgical treatments are generally used. These non-surgical treatments include many physical therapy interventions such as occlusal splints, medical treatments, bite plates, ultrasound and subcutaneous electrical nerve stimulation, and low-level laser therapies. With these intraorally used occlusal splints, a balanced occlusal contact is achieved without applying any force to the mandible in the resting position. Occlusal splints are available in different designs and different construction materials. The stabilization splint, which is one of the most commonly used occlusal splints, and the modified Hawley splint are appliances produced from hard materials. However, some researchers have commented that soft spints produced from resilient materials may also be useful in the distribution of excessive force formed in parafunctional habits. While there are studies stating that hard splints provide more successful results than soft splints in the functional problems of the chewing system, there are also studies reporting that they have similar efficacy on muscle pain after short-term use.

Extracorporeal shock wave therapy (ESWT), another physical therapy modality, used in the treatment of various joint and muscle pains; it is an advantageous treatment modality that is non-invasive, well tolerated by patients and has few side effects. This modality is also used in diseases of the TMJ and masticatory muscles in various sources. The availability of different non-standard treatment regimens and the few studies on the short-term results of ESWT applications make the use of ESWT in the treatment of TMJ diseases still unclear and new studies are needed.

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Key information

Conditions

Temporomandibular Joint Disc Displacement, With Reduction Extracorporeal Shock Wave Therapy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beyza Ünalan Değirmenci

Van, 65080, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with reduced disc displacement according to DC/TMD examination criteria
  • 18-70 years old
  • No systemic disease that may have effects on masticatory muscles or TMJ
  • Individuals who do not have any tooth loss other than 3. molar teeth and accept the treatments to be done

Exclusion criteria

  • Individuals with total or distal extension partial dentures
  • Individuals who have previously received medical, pharmacological, or any form of treatment for TMD
  • Individuals with recent facial or cervical trauma
  • Individuals with the syndrome who have the potential to affect any component of the stomagnatic system
  • Individuals with parafunctional habits such as clenching or grinding their teeth.

Treatment and study plan

Extracorporeal Shock Wave Therapy

Device

Extracorporeal shock wave therapy (ESWT) is an expedient remedy that is used in various joint and non-invasive muscle pain treatments

Primary outcomes

  1. VAS pain score

    Time frame: At baseline

    A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.

  2. VAS pain score

    Time frame: 1 week

    A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.

  3. VAS pain score

    Time frame: 2 week

    A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.

  4. Painless Maximum Active Mouth Opening

    Time frame: At baseline

    Measurement with one exception (pain-free opening), every time the patients moves his/her mouth vertically or excursively, he or she is instructed to move it as far as possible in that direction in milimeter.

  5. Painless Maximum Active Mouth Opening

    Time frame: 1 week

    Measurement with one exception (pain-free opening), every time the patients moves his/her mouth vertically or excursively, he or she is instructed to move it as far as possible in that direction in milimeter.

  6. Painless Maximum Active Mouth Opening

    Time frame: 2 week

    Measurement with one exception (pain-free opening), every time the patients moves his/her mouth vertically or excursively, he or she is instructed to move it as far as possible in that direction in milimeter.

  7. Passive Forced Mouth Opening

    Time frame: At baseline

    Measurement of movements for range of motion and for joint sounds are made with actively pushed on by the examiner in milimeter.

  8. Passive Forced Mouth Opening

    Time frame: 1 week

    Measurement of movements for range of motion and for joint sounds are made with actively pushed on by the examiner in milimeter.

  9. Passive Forced Mouth Opening

    Time frame: 2 week

    Measurement of movements for range of motion and for joint sounds are made with actively pushed on by the examiner in milimeter.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

Evaluation of the Clinical Efficacy of Extracorporeal Shock Wave Therapy in Temporomandibular Joint Patients Having Disc Displacement With Reduction

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 31, 2022
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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