The Use of Earplugs on Temporomandibular Joint

Not Applicable

Completed

• Conditions: Ear Protective Devices; Physical Therapy Modalities; Temporomandibular Joint Disorders
• Interventions: Device: occlusal splint; Device: Earplug; Other: exercise

• Registration Number: NCT05362877
• Lead Sponsor: Istanbul University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-05
• Study Start: 2023-04-01
• Primary Completion: 2023-08-03
• Study Completion: 2023-12-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-31
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Splint	occlusal splint	Occlusal splint group- using occlusal splints, n=20 Patients will use only occlusal splints
Earplug	Earplug	Earplug group- using earplugs, n=20 Patients will use only earplugs
Physical	exercise	Exercise group- using physical therapy, n=20 Patients will do only exercise
Earplug and splint	Earplug	Earplug group- using earplugs and splints, n=20 Patients will use both interventions
Earplug and splint	occlusal splint	Earplug group- using earplugs and splints, n=20 Patients will use both interventions
Earplug and Physical	Earplug	Earplug group- using earplugs and exercise, n=20 Patients will use both interventions
Earplug and Physical	exercise	Earplug group- using earplugs and exercise, n=20 Patients will use both interventions

Primary Outcome Measures

Name	Time	Method
Values of maximal mouth opening(millimeter)	2 months	Evaluating mouth opening by using digital caliper

Secondary Outcome Measures

Name	Time	Method
Pain perception	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)

Trial Locations

Locations (1)

Istanbul university,Faculty of Dentistry; 🇹🇷 Fatih, Turkey