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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05362877
Other study ID # 1302
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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