NCT04277052

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

3 years

First QC Date

February 16, 2020

Last Update Submit

January 1, 2021

Conditions

Keywords

Temporomandibular Joint DisordersUltrasonographyCross sectional

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1

Study Arms (5)

Group 1

EXPERIMENTAL

Muscle disorders

Device: Determination muscles sections by Ultrasonography

Group 2

EXPERIMENTAL

Disc displacements

Device: Determination muscles sections by Ultrasonography

Group 3

EXPERIMENTAL

Other common joint disorders

Device: Determination muscles sections by Ultrasonography

Group 4

EXPERIMENTAL

Mix type

Device: Determination muscles sections by Ultrasonography

Group 5

EXPERIMENTAL

Healthy individuals

Device: Determination muscles sections by Ultrasonography

Interventions

Determination muscles sections by Ultrasonography

Group 1Group 2Group 3Group 4Group 5

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halime ARIKAN

Ankara, Yenimahalle, 06560, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, Physiotherapist, MSc

Study Record Dates

First Submitted

February 16, 2020

First Posted

February 20, 2020

Study Start

April 1, 2019

Primary Completion

April 1, 2022

Study Completion

December 1, 2022

Last Updated

January 5, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR

Locations