- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04951908
Correlation Between Types of Lateral Pterygoid Muscle Attachment and Internal Derangement of the Temporomandibular Joint (LPM & TMJ)
July 6, 2021 updated by: Ayman Hegab, Al-Azhar University
Correlation Between Types of Lateral Pterygoid Muscle Attachment, Type of Disk Displacement and Osteoarthritic Changes of the Temporomandibular Joint
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.
Study Overview
Detailed 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.
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
No
Genders Eligible for Study
All
Sampling Method
Non-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.
Description
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 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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
control group
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 |
---|---|---|
VAS
Time Frame: baseline (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.
|
baseline (pre treatment)
|
mouth opening
Time Frame: baseline (pre treatment)
|
maximum nonassisted (voluntary) mouth opening (MVMO) in millimetres
|
baseline (pre treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
joint sound
Time Frame: baseline (pre treatment)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
November 30, 2019
Primary Completion (Actual)
December 30, 2020
Study Completion (Actual)
January 30, 2021
Study Registration Dates
First Submitted
June 29, 2021
First Submitted That Met QC Criteria
July 6, 2021
First Posted (Actual)
July 7, 2021
Study Record Updates
Last Update Posted (Actual)
July 7, 2021
Last Update Submitted That Met QC Criteria
July 6, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUAREC20190511-11
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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