Clinical & MRI Finding of TMJ Disk Perforation

Sponsor
Al-Azhar University (Other)
Overall Status
Completed
CT.gov ID
NCT04942743
Collaborator
(none)
900
1
17.1
52.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: MRI

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 Design

Study Type:
Observational
Actual Enrollment :
900 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Clinical & MRI Finding of TMJ Disk Perforation
Actual Study Start Date :
Jan 12, 2020
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Jun 15, 2021

Arms and Interventions

Arm Intervention/Treatment
control group

patients with normal TMJ

Diagnostic Test: MRI
MRI OF TMJ

Study group

patients with TMJ internal derangement

Diagnostic Test: MRI
MRI OF TMJ

Outcome Measures

Primary Outcome Measures

  1. joint pain (VAS), [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.

  2. (MVMO) [pretreatment]

    mouth opening

Secondary Outcome Measures

  1. joint sound [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dental Medicine Alazhar University Cairo Nasr City Egypt 11765

Sponsors and Collaborators

  • Al-Azhar University

Investigators

  • Principal Investigator: Ayman Hegab, Phd, ALAZHAR UNIVERSITY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ayman Hegab, associate professor of oral and maxillofacial surgery, Al-Azhar University
ClinicalTrials.gov Identifier:
NCT04942743
Other Study ID Numbers:
  • AUAREC20200501-12
First Posted:
Jun 28, 2021
Last Update Posted:
Jul 1, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 1, 2021