Clinical & MRI Finding of TMJ Disk Perforation

June 29, 2021 updated by: Ayman Hegab, Al-Azhar University
the study aimed to evaluate the clinical and MRI finding of TMJ with disk perforation with predication of the risk factors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Exclusion Inclusion criteria: 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.

the study included 2 groups group 1: normal TMJ patients group 2: patients with TMJ internal derangement

Study Type

Observational

Enrollment (Actual)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nasr City
      • Cairo, Nasr City, Egypt, 11765
        • Faculty of Dental Medicine Alazhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The sample originally included patients who provided consent to participate in this study and who ultimately underwent treatment for TMJD between 2008 and 2019.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control group
patients with normal TMJ
MRI OF TMJ
Study group
patients with TMJ internal derangement
MRI OF TMJ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
joint pain (VAS),
Time Frame: pre treatment
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.
pre treatment
(MVMO)
Time Frame: pretreatment
mouth opening
pretreatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
joint sound
Time Frame: pretreatment
joint sound was then determined by combining 3 means: (1) palpation of the TMJ zone by the clinician, (2) the patient's self-reporting regarding whether the joint sound could be heard, and (3) auscultation of the TMJ zone with the stethoscope.
pretreatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ayman Hegab, Phd, AlAzhar university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

June 15, 2021

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

June 24, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • AUAREC20200501-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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