Ear Protective DevicesNCT05362877
The Use of Earplugs on Temporomandibular Joint
A study testing Earplug, occlusal splint and exercise in people with Ear Protective Devices and Temporomandibular Joint Disorders, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The term temporomandibular joint disorder (TMD) refers to a group of disorders affecting the temporomandibular joint and/or muscles of mastication. Typical symptoms are; joint noises, pain, and limited mouth opening. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ear Protective Devices, Temporomandibular Joint Disorders, Physical Therapy Modalities
- What is being tested?
- Earplug, occlusal splint and exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 3 Dec 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pain in masticatory muscles for at least 3 months according to the DC/TMD
- Having a stable medication regimen for at least 1 month
- Age of 18-65 years
- Minimum pain intensity of 50 mm on a 100 mm visual analog scale (VAS)
- No concomitant systemic disease
- Natural posterior occlusion.
Who cannot join
- Undergoing physical therapy
- Using muscle relaxants and/or NSAIDs
- Previous TMD treatment more recently than one year
- Major psychosocial problems
- Undergoing orthodontic treatment
- Wearing removable prosthesis
- Pregnancy
- History of facial trauma.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul university,Faculty of Dentistry
Fatih, 34452
About this study
Official title: The Effect of Earplugs on Myogenous Temporomandibular Disorders
The term temporomandibular joint disorder (TMD) refers to a group of disorders affecting the temporomandibular joint and/or muscles of mastication. Typical symptoms are; joint noises, pain, and limited mouth opening. Many therapeutic modalities have been advocated for the treatment of TMD as intraoral splints, laser, ultrasound, physical therapy, surgery, and medications with inconsistent reported results due to the multifactorial etiology of this disorder. Although intraoral splints are the most widely used therapy, it has some drawbacks as being inconvenient for the patient due to their relatively large size interferes with eating and affects speech, therefore their use is mostly limited to sleeping time, which decreases its effectiveness.
Recently some commercial earplugs that claim to treat TMD have been introduced, however, there is no validated data regarding these appliances. Thus, this study aimss to evaluate the possible effect of earplugs on myogenous TMD.
- Being tested
- Earplug, occlusal splint, exercise
- Keywords
- Splints
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EarplugDevice
Using earplugs to reduce the symptoms of temporomandibular disorder
occlusal splintDevice
Using occlusal splints to reduce the symptoms of temporomandibular disorder
exerciseOther
Applying exercise to reduce the symptoms of temporomandibular disorder
| Study group | Role | What they receive |
|---|---|---|
| Earplug | Experimental | Earplug group- using earplugs, n=20 Patients will use only earplugs Receives: Device: Earplug |
| Splint | Experimental | Occlusal splint group- using occlusal splints, n=20 Patients will use only occlusal splints Receives: Device: occlusal splint |
| Physical | Experimental | Exercise group- using physical therapy, n=20 Patients will do only exercise Receives: Other: exercise |
| control group | No intervention | Control group-no intervention, n=20 |
| Earplug and splint | Experimental | Earplug group- using earplugs and splints, n=20 Patients will use both interventions Receives: Device: Earplug; Device: occlusal splint |
| Earplug and Physical | Experimental | Earplug group- using earplugs and exercise, n=20 Patients will use both interventions Receives: Device: Earplug; Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Values of maximal mouth opening(millimeter)
Evaluating mouth opening by using digital caliper
Measured: 2 months
Secondary outcomes (1)
Pain perception
Evaluating pain perception of the patients by using visual analogue scale and measuring pain response with self-evaluation and reporting (Minimum value: 0; maximum value:10)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Apr 2023
- Primary completion3 Aug 2023
- Study completion3 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ear Protective DevicesStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised controlled clinical trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Merve Benli, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362877
- Sponsor's protocol ID
- 1302
- Status last verified
- Mar 2024
- First submitted
- 25 Jan 2022
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Earplugs on Myogenous Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT05362877
- Acronym / sponsor ID
- 1302
- Keywords
- Splints
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 3 Dec 2023 (actual)
- First posted
- 5 May 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 term temporomandibular joint disorder (TMD) refers to a group of disorders affecting the temporomandibular joint and/or muscles of mastication. Typical symptoms are; joint noises, pain, and limited mouth opening. Many therapeutic modalities have been advocated for the treatment of TMD as intraoral splints, laser, ultrasound, physical therapy, surgery, and medications with inconsistent reported results due to the multifactorial etiology of this disorder. Although intraoral splints are the most widely used therapy, it has some drawbacks as being inconvenient for the patient due to their relatively large size interferes with eating and affects speech, therefore their use is mostly limited to sleeping time, which decreases its effectiveness.
Recently some commercial earplugs that claim to treat TMD have been introduced, however, there is no validated data regarding these appliances. Thus, this study aimss to evaluate the possible effect of earplugs on myogenous TMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 6
- Model description
- randomised controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Earplug | Experimental | Device: EarplugEarplug group- using earplugs, n=20 Patients will use only earplugs |
| Splint | Experimental | Device: occlusal splintOcclusal splint group- using occlusal splints, n=20 Patients will use only occlusal splints |
| Physical | Experimental | Other: exerciseExercise group- using physical therapy, n=20 Patients will do only exercise |
| control group | No intervention | –Control group-no intervention, n=20 |
| Earplug and splint | Experimental | Device: Earplug, Device: occlusal splintEarplug group- using earplugs and splints, n=20 Patients will use both interventions |
| Earplug and Physical | Experimental | Device: Earplug, Other: exerciseEarplug group- using earplugs and exercise, n=20 Patients will use both interventions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pain in masticatory muscles for at least 3 months according to the DC/TMD
- Having a stable medication regimen for at least 1 month
- Age of 18-65 years
- Minimum pain intensity of 50 mm on a 100 mm visual analog scale (VAS)
- No concomitant systemic disease
Key exclusion criteria (8 listed)
- Undergoing physical therapy
- Using muscle relaxants and/or NSAIDs
- Previous TMD treatment more recently than one year
- Major psychosocial problems
- Undergoing orthodontic treatment
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 |
|---|---|---|
| EarplugUsing earplugs to reduce the symptoms of temporomandibular disorder | Device | Earplug, Earplug and Physical, Earplug and splint |
| occlusal splintUsing occlusal splints to reduce the symptoms of temporomandibular disorder | Device | Earplug and splint, Splint |
| exerciseApplying exercise to reduce the symptoms of temporomandibular disorder | Other | Earplug and Physical, Physical |
Primary outcome
Values of maximal mouth opening(millimeter)
Time frame: 2 months
Evaluating mouth opening by using digital caliper
1 secondary outcome
Pain perception
Time frame: 2 months
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 2 Apr 2024.
- Individual participant dataSharing planned: Undecided
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 Earplug, occlusal splint and exercise in people with Ear Protective Devices and Temporomandibular Joint Disorders, run by Istanbul 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 6 inclusion and 8 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 2 Apr 2024. 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?
Values of maximal mouth opening(millimeter) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2024.