Investigation of Masseter and Temporalis Muscles Sections in Individuals With Temporomandibular Disorders

Sponsor

Gazi University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04277052

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to examine masseter and temporal muscle sections with Ultrasonography in this individuals depending on the origin of Temporomandibular Disorders.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Joint Disorders	Device: Determination muscles sections by Ultrasonography	N/A

Detailed Description

Multidirectional evaluations are needed to examine the symptoms of Temporomandibular Disorders (TMD). Physical examination, questionnaires towards symptoms, and imaging techniques provide objective data on pathology. The chewing muscles should also be evaluated in this way and the approaches to be followed in subsequent processes should be determined. It is known that muscle sections are changed in TMD, which develops due to muscle disorders. However, regardless of the origin of TMD chewing muscles are affected depending on the condition.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Diagnostic

Official Title:

Investigation of Masseter and Temporalis Muscles Sections in Individuals With Temporomandibular Disorders

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Muscle disorders	Device: Determination muscles sections by Ultrasonography Determination muscles sections by Ultrasonography
Experimental: Group 2 Disc displacements	Device: Determination muscles sections by Ultrasonography Determination muscles sections by Ultrasonography
Experimental: Group 3 Other common joint disorders	Device: Determination muscles sections by Ultrasonography Determination muscles sections by Ultrasonography
Experimental: Group 4 Mix type	Device: Determination muscles sections by Ultrasonography Determination muscles sections by Ultrasonography
Experimental: Group 5 Healthy individuals	Device: Determination muscles sections by Ultrasonography Determination muscles sections by Ultrasonography

Outcome Measures

Primary Outcome Measures

Determination of the thickness of the masseter and temporalis muscles sections by Ultrasonography and the changes in the biomechanical properties of the masticatory muscles in individuals with temporomandibular disorders. [Day 1]
US has been described as an accurate and reliable imaging technique to assess the thickness and cross-sectional area of the chewing muscles and to determine changes in the local cross-sectional dimensions of the head and neck muscles in livings. It allows large-scale long-term studies of changes in the thickness of the jaw muscles during the development associated with changes in the biomechanical properties of the masticatory muscles.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Having a temporomandibular disorder,
Individuals who suited Temporomandibular Disorders/ Research Diagnostic Criteria classification

Exclusion Criteria:

Pregnant,
Canser,
Trauma,
Neurologic disorder,
Infection,
Trigeminal or postherpatic neuralgia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Halime ARIKAN	Ankara	Yenimahalle	Turkey	06560

Sponsors and Collaborators

Gazi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Halime ARIKAN, Research Assistant, Physiotherapist, MSc, Gazi University

ClinicalTrials.gov Identifier:

NCT04277052

Other Study ID Numbers:

2019-112

First Posted:

Feb 20, 2020

Last Update Posted:

Jan 5, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Halime ARIKAN, Research Assistant, Physiotherapist, MSc, Gazi University

Temporomandibular Joint Disorders

Ultrasonography

Cross sectional

Additional relevant MeSH terms:

Temporomandibular Joint Disorders

Temporomandibular Joint Dysfunction Syndrome

Joint Diseases

Disease

Study Results

No Results Posted as of Jan 5, 2021