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The Use of Earplugs on Temporomandibular Joint

The Effect of Earplugs on Myogenous Temporomandibular Disorders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05362877
Enrollment
120
Registered
2022-05-05
Start date
2023-04-01
Completion date
2023-12-03
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ear Protective Devices, Physical Therapy Modalities, Temporomandibular Joint Disorders

Keywords

Splints

Brief 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. 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.

Interventions

DEVICEEarplug

Using earplugs to reduce the symptoms of temporomandibular disorder

DEVICEocclusal splint

Using occlusal splints to reduce the symptoms of temporomandibular disorder

OTHERexercise

Applying exercise to reduce the symptoms of temporomandibular disorder

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Intervention model description

randomised controlled clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Values of maximal mouth opening(millimeter)2 monthsEvaluating mouth opening by using digital caliper

Secondary

MeasureTime frameDescription
Pain perception2 monthsEvaluating 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)

Other

MeasureTime frameDescription
Symptom Severity2 monthsEvaluating temporomandibuler symptoms by using Symptom Severity Index

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026