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The Use of Earplugs on Temporomandibular Joint

Primary Purpose

Ear Protective Devices, Temporomandibular Joint Disorders, Physical Therapy Modalities

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Earplug
occlusal splint
exercise
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ear Protective Devices focused on measuring Splints

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Istanbul university,Faculty of Dentistry
  • Ozel Maltepe Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

No Intervention

Experimental

Experimental

Arm Label

Earplug

Splint

Physical

control group

Earplug and splint

Earplug and Physical

Arm Description

Earplug group- using earplugs, n=30 Patients will use only earplugs

Occlusal splint group- using occlusal splints, n=30 Patients will use only occlusal splints

Exercise group- using physical therapy, n=30 Patients will do only exercise

Control group-no intervention, n=30

Earplug group- using earplugs and splints, n=30 Patients will use both interventions

Earplug group- using earplugs and exercise, n=30 Patients will use both interventions

Outcomes

Primary Outcome Measures

Values of maximal mouth opening(millimeter)
Evaluating mouth opening by using digital caliper

Secondary Outcome Measures

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)

Full Information

First Posted
January 25, 2022
Last Updated
April 27, 2023
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05362877
Brief Title
The Use of Earplugs on Temporomandibular Joint
Official Title
The Effect of Earplugs on Myogenous Temporomandibular Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
August 3, 2022 (Actual)
Study Completion Date
December 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ear Protective Devices, Temporomandibular Joint Disorders, Physical Therapy Modalities
Keywords
Splints

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomised controlled clinical trial
Masking
Care Provider
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Earplug
Arm Type
Experimental
Arm Description
Earplug group- using earplugs, n=30 Patients will use only earplugs
Arm Title
Splint
Arm Type
Experimental
Arm Description
Occlusal splint group- using occlusal splints, n=30 Patients will use only occlusal splints
Arm Title
Physical
Arm Type
Experimental
Arm Description
Exercise group- using physical therapy, n=30 Patients will do only exercise
Arm Title
control group
Arm Type
No Intervention
Arm Description
Control group-no intervention, n=30
Arm Title
Earplug and splint
Arm Type
Experimental
Arm Description
Earplug group- using earplugs and splints, n=30 Patients will use both interventions
Arm Title
Earplug and Physical
Arm Type
Experimental
Arm Description
Earplug group- using earplugs and exercise, n=30 Patients will use both interventions
Intervention Type
Device
Intervention Name(s)
Earplug
Intervention Description
Using earplugs to reduce the symptoms of temporomandibular disorder
Intervention Type
Device
Intervention Name(s)
occlusal splint
Intervention Description
Using occlusal splints to reduce the symptoms of temporomandibular disorder
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
Applying exercise to reduce the symptoms of temporomandibular disorder
Primary Outcome Measure Information:
Title
Values of maximal mouth opening(millimeter)
Description
Evaluating mouth opening by using digital caliper
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Pain perception
Description
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)
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Symptom Severity
Description
Evaluating temporomandibuler symptoms by using Symptom Severity Index
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Istanbul university,Faculty of Dentistry
City
Fatih
ZIP/Postal Code
34452
Country
Turkey
Facility Name
Ozel Maltepe Hospital
City
Istanbul
ZIP/Postal Code
34844
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Use of Earplugs on Temporomandibular Joint

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