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Completed

NCT Number: NCT05362877

The Use of Earplugs on Temporomandibular Joint

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.

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Key information

Conditions

Ear Protective Devices Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Physical Therapy Modalities Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul university,Faculty of Dentistry

Fatih, 34452, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Earplug

Device

Using earplugs to reduce the symptoms of temporomandibular disorder

Occlusal splint

Device

Using occlusal splints to reduce the symptoms of temporomandibular disorder

Exercise

Other

Applying exercise to reduce the symptoms of temporomandibular disorder

Primary outcomes

  1. Values of maximal mouth opening(millimeter)

    Time frame: 2 months

    Evaluating mouth opening by using digital caliper

Secondary outcomes

  1. Pain perception

    Time frame: 2 months

    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)

Other outcomes

  1. Symptom Severity

    Time frame: 2 months

    Evaluating temporomandibuler symptoms by using Symptom Severity Index

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

The Effect of Earplugs on Myogenous Temporomandibular Disorders

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 5, 2022
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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