The Use of Earplugs on Temporomandibular Joint

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: Temporomandibular Joint Disorders; Physical Therapy Modalities; Ear Protective Devices
• Intervention / Treatment: Device: Earplug; Device: occlusal splint; Other: exercise

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

6

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)	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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

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: Splints
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• 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