The Use of Earplugs on Temporomandibular Joint

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Earplugs on Myogenous Temporomandibular Disorders

Conditions
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Ear Protective Devices, Temporomandibular Joint Disorders, Physical Therapy Modalities

Intervention / Treatment
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* Device: Earplug
* Device: occlusal splint
* Other: exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomised controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Earplug<br>Earplug group- using earplugs, n=30 Patients will use only earplugs | Device: Earplug<br>* Using earplugs to reduce the symptoms of temporomandibular disorder<br>|
| Experimental: Splint<br>Occlusal splint group- using occlusal splints, n=30 Patients will use only occlusal splints | Device: occlusal splint<br>* Using occlusal splints to reduce the symptoms of temporomandibular disorder<br>|
| Experimental: Physical<br>Exercise group- using physical therapy, n=30 Patients will do only exercise | Other: exercise<br>* Applying exercise to reduce the symptoms of temporomandibular disorder<br>|
| No Intervention: control group<br>Control group-no intervention, n=30 | |
| Experimental: Earplug and splint<br>Earplug group- using earplugs and splints, n=30 Patients will use both interventions | Device: Earplug<br>* Using earplugs to reduce the symptoms of temporomandibular disorder<br>Device: occlusal splint<br>* Using occlusal splints to reduce the symptoms of temporomandibular disorder<br>|
| Experimental: Earplug and Physical<br>Earplug group- using earplugs and exercise, n=30 Patients will use both interventions | Device: Earplug<br>* Using earplugs to reduce the symptoms of temporomandibular disorder<br>Other: exercise<br>* Applying exercise to reduce the symptoms of temporomandibular disorder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Values of maximal mouth opening(millimeter) | Evaluating mouth opening by using digital caliper | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Splints