NCT04951895

Brief Summary

the study aimed to evaluate the clinical and MRI finding of TMJ with posterior disk displacement with predication of the risk factors

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 Feb 2020

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

February 20, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
14 days 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

12 months

First QC Date

June 29, 2021

Last Update Submit

July 6, 2021

Conditions

Keywords

posterior disk displacement

Outcome Measures

Primary Outcomes (2)

  • VAS

    posttreatment 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

patients with normal TMJ

Diagnostic Test: MRI

Study group

Patients with TMJ internal deragement

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:

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

You may not qualify if:

  • Patients were included if they were older than 18 years and diagnosed with TMJD. criteria for this study included systemic diseases (the presence of polyarthritis or other rheumatic diseases), contraindications for MRI (e.g., implanted metal or medical devices, claustrophobia), the presence of neurologic disorders, head and neck cancer, oral submucous fibrosis, a history of TMJ surgery, a history of previous nonsurgical treatment such as occlusal splints, and a history of joint injection with HA/PRP. Trauma patients with subcondylar fracture and patients with congenital and developmental disorders of the TMJ were also excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine Alazhar University

Cairo, Nasr City, 11765, Egypt

Location

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

February 20, 2020

Primary Completion

January 30, 2021

Study Completion

June 15, 2021

Last Updated

July 7, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations