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Can Extracorporeal Shock Wave Therapy Be Effective in Temporomandibular Joint Disease

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Extracorporeal Shock Wave Therapy
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disc Displacement, With Reduction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beyza Ünalan Değirmenci

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Extracorporeal Shock Wave Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 20, 2022
Last Updated
October 28, 2022
Sponsor
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT05599113
Brief Title
Can Extracorporeal Shock Wave Therapy Be Effective in Temporomandibular Joint Disease
Official Title
Evaluation of the Clinical Efficacy of Extracorporeal Shock Wave Therapy in Temporomandibular Joint Patients Having Disc Displacement With Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disc Displacement, With Reduction, Extracorporeal Shock Wave Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extracorporeal Shock Wave Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Extracorporeal Shock Wave Therapy
Intervention Description
Extracorporeal shock wave therapy (ESWT) is an expedient remedy that is used in various joint and non-invasive muscle pain treatments
Primary Outcome Measure Information:
Title
VAS pain score
Description
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Time Frame
At baseline
Title
VAS pain score
Description
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Time Frame
1 week
Title
VAS pain score
Description
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Time Frame
2 week
Title
Painless Maximum Active Mouth Opening
Description
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.
Time Frame
At baseline
Title
Painless Maximum Active Mouth Opening
Description
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.
Time Frame
1 week
Title
Painless Maximum Active Mouth Opening
Description
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.
Time Frame
2 week
Title
Passive Forced Mouth Opening
Description
Measurement of movements for range of motion and for joint sounds are made with actively pushed on by the examiner in milimeter.
Time Frame
At baseline
Title
Passive Forced Mouth Opening
Description
Measurement of movements for range of motion and for joint sounds are made with actively pushed on by the examiner in milimeter.
Time Frame
1 week
Title
Passive Forced Mouth Opening
Description
Measurement of movements for range of motion and for joint sounds are made with actively pushed on by the examiner in milimeter.
Time Frame
2 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Beyza Ünalan Değirmenci
City
Van
ZIP/Postal Code
65080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35453651
Citation
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.
Results Reference
result
PubMed Identifier
24549763
Citation
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.
Results Reference
result
PubMed Identifier
27504532
Citation
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.
Results Reference
result

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Can Extracorporeal Shock Wave Therapy Be Effective in Temporomandibular Joint Disease

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