NCT05362877

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2023

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

January 25, 2022

Last Update Submit

March 31, 2024

Conditions

Ear Protective DevicesTemporomandibular Joint DisordersPhysical Therapy Modalities

Keywords

Splints

Outcome Measures

Primary Outcomes (1)

  • Values of maximal mouth opening(millimeter)

    Evaluating mouth opening by using digital caliper

    2 months

Secondary Outcomes (1)

  • Pain perception

    2 months

Other Outcomes (1)

  • Symptom Severity

    2 months

Study Arms (6)

Earplug

EXPERIMENTAL

Earplug group- using earplugs, n=20 Patients will use only earplugs

Device: Earplug

Splint

EXPERIMENTAL

Occlusal splint group- using occlusal splints, n=20 Patients will use only occlusal splints

Device: occlusal splint

Physical

EXPERIMENTAL

Exercise group- using physical therapy, n=20 Patients will do only exercise

Other: exercise

control group

NO INTERVENTION

Control group-no intervention, n=20

Earplug and splint

EXPERIMENTAL

Earplug group- using earplugs and splints, n=20 Patients will use both interventions

Device: EarplugDevice: occlusal splint

Earplug and Physical

EXPERIMENTAL

Earplug group- using earplugs and exercise, n=20 Patients will use both interventions

Device: EarplugOther: exercise

Interventions

EarplugDEVICE

Using earplugs to reduce the symptoms of temporomandibular disorder

EarplugEarplug and PhysicalEarplug and splint
occlusal splintDEVICE

Using occlusal splints to reduce the symptoms of temporomandibular disorder

Earplug and splintSplint
exerciseOTHER

Applying exercise to reduce the symptoms of temporomandibular disorder

Earplug and PhysicalPhysical

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul university,Faculty of Dentistry

Fatih, 34452, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Ear Protective DevicesOcclusal SplintsExercise

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Personal Protective EquipmentProtective DevicesEquipment and SuppliesProtective ClothingClothingManufactured MaterialsTechnology, Industry, and AgricultureOrthotic DevicesOrthopedic EquipmentSurgical EquipmentMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomised controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 25, 2022

First Posted

May 5, 2022

Study Start

April 1, 2023

Primary Completion

August 3, 2023

Study Completion

December 3, 2023

Last Updated

April 2, 2024

Record last verified: 2024-03

Locations

TU(1)