The Use of Earplugs on Temporomandibular Joint

March 31, 2024 updated by: Dr. Merve Benli, Istanbul University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Fatih, Turkey, 34452
        • Istanbul university,Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Earplug
Earplug group- using earplugs, n=20 Patients will use only earplugs
Device: Earplug
Using earplugs to reduce the symptoms of temporomandibular disorder
Experimental: Splint
Occlusal splint group- using occlusal splints, n=20 Patients will use only occlusal splints
Device: occlusal splint
Using occlusal splints to reduce the symptoms of temporomandibular disorder
Experimental: Physical
Exercise group- using physical therapy, n=20 Patients will do only exercise
Other: exercise
Applying exercise to reduce the symptoms of temporomandibular disorder
No Intervention: control group
Control group-no intervention, n=20
Experimental: Earplug and splint
Earplug group- using earplugs and splints, n=20 Patients will use both interventions
Device: Earplug
Using earplugs to reduce the symptoms of temporomandibular disorder
Device: occlusal splint
Using occlusal splints to reduce the symptoms of temporomandibular disorder
Experimental: Earplug and Physical
Earplug group- using earplugs and exercise, n=20 Patients will use both interventions
Device: Earplug
Using earplugs to reduce the symptoms of temporomandibular disorder
Other: exercise
Applying exercise to reduce the symptoms of temporomandibular disorder

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Severity
Time Frame: 2 months
Evaluating temporomandibuler symptoms by using Symptom Severity Index
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

August 3, 2023

Study Completion (Actual)

December 3, 2023

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 5, 2022

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 31, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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