Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-01-03 @ 8:39 PM
Study NCT ID:
NCT04951895
Status:
COMPLETED
Last Update Posted:
2021-07-07
First Post:
2021-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and MRI Finding of The Temporomandibular Joint Posterior Disk Displacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-06', 'studyFirstSubmitDate': '2021-06-29', 'studyFirstSubmitQcDate': '2021-07-06', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS', 'timeFrame': 'baseline (pre treatment)', 'description': '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.'}, {'measure': 'mouth opening', 'timeFrame': 'baseline (pre treatment)', 'description': 'maximum nonassisted (voluntary) mouth opening (MVMO) in millimetres'}], 'secondaryOutcomes': [{'measure': 'joint sound', 'timeFrame': 'baseline (pre treatment)', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['posterior disk displacement'], 'conditions': ['TMJ Disc Disorder']}, 'descriptionModule': {'briefSummary': 'the study aimed to evaluate the clinical and MRI finding of TMJ with posterior disk displacement with predication of the risk factors', 'detailedDescription': ': the study aimed to evaluate the clinical and MRI finding of TMJ with posterior disk displacement 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT04951895', 'acronym': 'Posterior Disk', 'briefTitle': 'Clinical and MRI Finding of The Temporomandibular Joint Posterior Disk Displacement', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Clinical and MRI Finding of The Temporomandibular Joint Posterior Disk Displacement', 'orgStudyIdInfo': {'id': 'AUAREC20190512-12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control group', 'description': 'patients with normal TMJ', 'interventionNames': ['Diagnostic Test: MRI']}, {'label': 'Study group', 'description': 'Patients with TMJ internal deragement', 'interventionNames': ['Diagnostic Test: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'MRI of TMJ', 'armGroupLabels': ['Study group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11765', 'city': 'Cairo', 'state': 'Nasr City', 'country': 'Egypt', 'facility': 'Faculty of Dental Medicine Alazhar University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor of oral and maxillofacial surgery', 'investigatorFullName': 'Ayman Hegab', 'investigatorAffiliation': 'Al-Azhar University'}}}}