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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04951908
Other study ID # AUAREC20190511-11
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 30, 2019
Est. completion date January 30, 2021

Study information

Verified date June 2021
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

the study aimed to evaluate the clinical and MRI finding of TMJ with LPM with predication of the risk factors. Study design: this retrospective study included 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.


Recruitment information / eligibility

Status Completed
Enrollment 900
Est. completion date January 30, 2021
Est. primary completion date December 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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 ?brosis, 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
MRI
MRI of TMJ

Locations

Country Name City State
Egypt Faculty of Dental Medicine Alazhar University Cairo Nasr City

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary mouth opening maximum nonassisted (voluntary) mouth opening (MVMO) in millimetres baseline (pre treatment)
Secondary joint sound and the 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. baseline (pre treatment)
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