The Use of Earplugs on Temporomandibular Joint

Istanbul University

Status: Completed

Conditions: Temporomandibular Joint Disorders; Ear Protective Devices; Physical Therapy Modalities

Treatments: Other: exercise; Device: occlusal splint; Device: Earplug

Study type: Interventional

Funder types: Other

Identifiers

NCT05362877

1302

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 6 patient groups

Earplug

Experimental group

Description:

Earplug group- using earplugs, n=20 Patients will use only earplugs

Treatment:

Device: Earplug

Splint

Experimental group

Description:

Occlusal splint group- using occlusal splints, n=20 Patients will use only occlusal splints

Treatment:

Device: occlusal splint

Physical

Experimental group

Description:

Exercise group- using physical therapy, n=20 Patients will do only exercise

Treatment:

Other: exercise

control group

No Intervention group

Description:

Control group-no intervention, n=20

Earplug and splint

Experimental group

Description:

Earplug group- using earplugs and splints, n=20 Patients will use both interventions

Treatment:

Device: occlusal splint

Device: Earplug

Earplug and Physical

Experimental group

Description:

Earplug group- using earplugs and exercise, n=20 Patients will use both interventions

Treatment:

Other: exercise

Device: Earplug