The Use of Earplugs on Temporomandibular Joint

Temporomandibular Joint Disorders Clinical Trial

Official title:

The Effect of Earplugs on Myogenous Temporomandibular Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05362877
• Other study ID #: 1302
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 3, 2023

Study information

• Verified date: March 2024
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 3, 2023
• Est. primary completion date: August 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Therapy Modalities
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Device:
• Earplug
Using earplugs to reduce the symptoms of temporomandibular disorder
• occlusal splint
Using occlusal splints to reduce the symptoms of temporomandibular disorder

Other:
• exercise
Applying exercise to reduce the symptoms of temporomandibular disorder

Locations

Country	Name	City	State
Turkey	Istanbul university,Faculty of Dentistry	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptom Severity	Evaluating temporomandibuler symptoms by using Symptom Severity Index	2 months
Primary	Values of maximal mouth opening(millimeter)	Evaluating mouth opening by using digital caliper	2 months
Secondary	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