Temporomandibular Joint Disc Displacement, With ReductionNCT05599113
Can Extracorporeal Shock Wave Therapy Be Effective in Temporomandibular Joint Disease
A study testing Extracorporeal Shock Wave Therapy in people with Temporomandibular Joint Disc Displacement, With Reduction and Extracorporeal Shock Wave Therapy, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Temporomandibular Joint Disc Displacement, With Reduction, Extracorporeal Shock Wave Therapy
- What is being tested?
- Extracorporeal Shock Wave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Feb 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Clinical Efficacy of Extracorporeal Shock Wave Therapy in Temporomandibular Joint Patients Having Disc Displacement With Reduction
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
- Being tested
- Extracorporeal Shock Wave Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave TherapyDevice
Extracorporeal shock wave therapy (ESWT) is an expedient remedy that is used in various joint and non-invasive muscle pain treatments
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Extracorporeal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Measured: At baseline
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Measured: 1 week
VAS pain score
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Jan 2020
- Primary completion30 Jan 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint Disc Displacement, With ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Keskin Tunc, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599113
- Sponsor's protocol ID
- 29.01.2020/14
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35453651Falkensammer 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.
PubMed 24549763Pfaff 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.
PubMed 27504532Keskin 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.
PubMed 39470554
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Efficacy of Extracorporeal Shock Wave Therapy in Temporomandibular Joint Patients Having Disc Displacement With Reduction
- ClinicalTrials.gov ID
- NCT05599113
- Acronym / sponsor ID
- 29.01.2020/14
- Conditions
- Temporomandibular Joint Disc Displacement, With Reduction, Extracorporeal Shock Wave Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Shock Wave Therapy | Experimental | Device: Extracorporeal Shock Wave TherapyExtracorporeal 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shock Wave TherapyExtracorporeal shock wave therapy (ESWT) is an expedient remedy that is used in various joint and non-invasive muscle pain treatments | Device | Extracorporeal Shock Wave Therapy |
Primary outcome
VAS pain score
Time frame: At baseline
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score
Time frame: 1 week
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
VAS pain score
Time frame: 2 week
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Results publication: PubMed 35453651Alshihri 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 publication: PubMed 24549763Falkensammer 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 publication: PubMed 27504532Pfaff 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.
- Derived from this study: PubMed 39470554Keskin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy in people with Temporomandibular Joint Disc Displacement, With Reduction and Extracorporeal Shock Wave Therapy, run by Yuzuncu Yil 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 4 inclusion and 5 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 31 Oct 2022. 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?
VAS pain score (time frame: At baseline). The study lists 9 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 NCT05599113, which also lists 4 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 31 Oct 2022.