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

Primary Purpose

Temporomandibular Joint Disorders

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Determination muscles sections by Ultrasonography

About this trial

This is an interventional diagnostic trial for Temporomandibular Joint Disorders focused on measuring Temporomandibular Joint Disorders, Ultrasonography, Cross sectional

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Halime ARIKANRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Arm Description

Muscle disorders

Disc displacements

Other common joint disorders

Mix type

Healthy individuals

Outcomes

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04277052

First Posted

February 16, 2020

Last Updated

January 1, 2021

Sponsor

Gazi University

1. Study Identification

Unique Protocol Identification Number

NCT04277052

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

April 1, 2022 (Anticipated)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Temporomandibular Joint Disorders

Keywords

Temporomandibular Joint Disorders, Ultrasonography, Cross sectional

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Non-Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Muscle disorders

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Disc displacements

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Other common joint disorders

Arm Title

Group 4

Arm Type

Experimental

Arm Description

Mix type

Arm Title

Group 5

Arm Type

Experimental

Arm Description

Healthy individuals

Intervention Type

Device

Intervention Name(s)

Determination muscles sections by Ultrasonography

Intervention Description

Determination muscles sections by Ultrasonography

Primary Outcome Measure Information:

Title

Description

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Halime ARIKAN

City

Ankara

State/Province

Yenimahalle

ZIP/Postal Code

06560

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Halime ARIKAN, MSc

Phone

05465765132

halimearikan92@hotmail.com

First Name & Middle Initial & Last Name & Degree

Seyit ÇITAKER, Prof. Dr.

Phone

05336212449

scitaker@gazi.edu.tr

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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