NCT04348331

Brief Summary

In the present study, investigators are going to investigate the potential of inversion recovery (fluid attenuated inversion recovery -FLAIR and short-TI Inversion Recovery -STIR) sequence images to demonstrate joint effusion, compared to T2-weighted images.

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
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

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, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

11 months

First QC Date

April 9, 2020

Last Update Submit

April 15, 2020

Conditions

Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (1)

  • Identification of temporomandibular joint effusion.

    Binary outcome measure

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Delineation of temporomandibular joint disc position.

    through study completion, an average of 1 year

Interventions

Dual echo MRI sequenceDIAGNOSTIC_TEST

new MRI sequences for imaging of joints

Also known as: Fluid-attenuated inversion recovery (FLAIR) MRI sequence, Short-TI Inversion Recovery (STIR) MRI sequence

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with pain related to temporomandibular joint.
  • Patients with limited mouth opening.

You may not qualify if:

  • Patients with pain related to temporomandibular joint for less than one month duration.
  • Patients with limited mouth opening for less than one month duration.
  • Patients with history of TMJ surgical intervention.
  • Patients with history of TMJ arthrocentesis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nouran Nabil Marzaban

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Mohamed K Zayet

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Nouran N Marzaban

CONTACT

+201006891841nouran.marzaban@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Oral and Maxillofacial Radiology

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 16, 2020

Study Start

April 1, 2020

Primary Completion

March 1, 2021

Study Completion

June 1, 2021

Last Updated

April 16, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)