NCT04951908

Brief Summary

the study aimed to evaluate the clinical and MRI finding of TMJ AND LPM with predication of the risk factors. Study design: this retrospective study included 1365 joints in 800 patients diagnosed as TMJ internal derangement and all the patients examined by MRI from 2008 to 2019. Cases with loss of continuity of articular disk or the posterior attachment of the disk were considered as positive cases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

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

November 30, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
Last Updated

July 7, 2021

Status Verified

June 1, 2021

Enrollment Period

1.1 years

First QC Date

June 29, 2021

Last Update Submit

July 6, 2021

Conditions

TMJ Disorder

Outcome Measures

Primary Outcomes (2)

  • VAS

    pain index scores were measured using a 10-point visual analogue scale (VAS), with 0 indicating absence of pain and 10 indicating the worst pain.

    baseline (pre treatment)

  • mouth opening

    maximum nonassisted (voluntary) mouth opening (MVMO) in millimetres

    baseline (pre treatment)

Secondary Outcomes (1)

  • joint sound

    baseline (pre treatment)

Study Arms (2)

control group

NORMAL TMJ

Diagnostic Test: MRI

Study group

Patients with TMJ internal derangement

Diagnostic Test: MRI

Interventions

MRIDIAGNOSTIC_TEST

MRI of TMJ

Study groupcontrol group

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The retrospective study included patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University. The sample originally included patients who provided consent to participate in this study and who ultimately underwent treatment for TMJD between 2008 and 2019.

You may qualify if:

  • \- study included patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine Alazhar University

Cairo, Nasr City, 11765, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor of oral and maxillofacial surgery

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 7, 2021

Study Start

November 30, 2019

Primary Completion

December 30, 2020

Study Completion

January 30, 2021

Last Updated

July 7, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)