Can Extracorporeal Shock Wave Therapy Be Effective in Temporomandibular Joint Disease

NCT05599113 | Completed

• 1 other identifier: 29.01.2020/14
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Temporomandibular Joint Disc Displacement, With Reduction; Extracorporeal Shock Wave Therapy

Outcome Measures

Primary Outcomes (9)

• VAS pain score

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

  At baseline

• VAS pain score

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

  1 week

• VAS pain score

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

  2 week

• Painless Maximum Active Mouth Opening

  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.

  At baseline

• Painless Maximum Active Mouth Opening

  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.

  1 week

• Painless Maximum Active Mouth Opening

  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.

  2 week

• Passive Forced Mouth Opening

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

  At baseline

• Passive Forced Mouth Opening

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

  1 week

• Passive Forced Mouth Opening

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

  2 week

Study Arms (1)

Extracorporeal Shock Wave Therapy

EXPERIMENTAL

Extracorporeal shock wave therapy (ESWT) is an expedient remedy that is used in various joint and muscle pain treatments, is non-invasive, is well tolerated by patients, and has few side effects.

Device: Extracorporeal Shock Wave Therapy

Interventions

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

Extracorporeal Shock Wave Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with reduced disc displacement according to DC/TMD examination criteria
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Beyza Ünalan Değirmenci

Van, 65080, Turkey (Türkiye)

Location

Related Publications (4)

• Alshihri A. Translational Applications of Extracorporeal Shock Waves in Dental Medicine: A Literature Review. Biomedicines. 2022 Apr 14;10(4):902. doi: 10.3390/biomedicines10040902.

  PMID: 35453651 RESULT

• Falkensammer F, Arnhart C, Krall C, Schaden W, Freudenthaler J, Bantleon HP. Impact of extracorporeal shock wave therapy (ESWT) on orthodontic tooth movement-a randomized clinical trial. Clin Oral Investig. 2014 Dec;18(9):2187-92. doi: 10.1007/s00784-014-1199-0. Epub 2014 Feb 19.

  PMID: 24549763 RESULT

• Pfaff JA, Boelck B, Bloch W, Nentwig GH. Growth Factors in Bone Marrow Blood of the Mandible With Application of Extracorporeal Shock Wave Therapy. Implant Dent. 2016 Oct;25(5):606-12. doi: 10.1097/ID.0000000000000452.

  PMID: 27504532 RESULT

• Keskin Tunc S, Unalan Degirmenci B, Bilen M, Toprak ME, Kaplan S, Turan M. Can extracorporeal shock wave therapy be effective in temporomandibular joint disorder?: A pilot study. Medicine (Baltimore). 2024 Oct 25;103(43):e40052. doi: 10.1097/MD.0000000000040052.

  PMID: 39470554 DERIVED

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 31, 2022
• Study Start: January 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: February 1, 2021
• Last Updated: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)