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

January 1, 2021 updated by: Halime ARIKAN, Gazi University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

February 16, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

January 1, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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