Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT06205667
Status:
COMPLETED
Last Update Posted:
2024-01-16
First Post:
2024-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Computer Guided Versus Conventional Arthrocentesis in Management of Internal Derangements: A Randomized Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2024-01-04', 'studyFirstSubmitQcDate': '2024-01-04', 'lastUpdatePostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attempts number of needle puncture', 'timeFrame': 'intraoperative'}, {'measure': 'Operation time started from first needle insertion.', 'timeFrame': 'intaoperative'}], 'secondaryOutcomes': [{'measure': 'Maximum mouth opening', 'timeFrame': '1week, 1, 3 and 6', 'description': 'Change of mouth opening measurement using RDC/TMD'}, {'measure': 'Pain reduction', 'timeFrame': '1week, 1, 3 and 6', 'description': 'Pain assessment using Visual analogue Scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TMJ - Oral &Maxillofacial Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the applicability, accuracy, benefits and the efficacy of 3-dimensional, printed, patient-specific guides to direct TMJ access for arthrocentesis when performed in contrast with conventional arthrocentesis of TMJ.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who complain from signs and symptoms of internal derangements and were diagnosed by the RDC/TMD as having disc displacement with/ without reduction with / without limitation associated with arthralgia or as having disc displacement with reduction associated with arthralgia in a presence or absence of joint sounds.\n* Patients who did not responded to conservative treatment for a minimum of 3 months.\n* Obtaining written informed consents signed by the patients.\n\nExclusion Criteria:\n\n* Patients suffering from any muscular disorders as myofascial pain or myofascial pain with limitations\n* If the disc was not visible in the MRI examination.\n* Patients who previously received intra-articular injection of any medication or exposed to any other TMJ invasive procedure.\n* Patients who suffer from any connective tissue diseases as rheumatoid arthritis or neurologic disorders.\n* Patients with history of major jaw trauma, bisphosphonate-derived drug use, pregnancy, alcohol or drug dependence.\n* Patients with gross mechanical restrictions or history of adhesion (fibrous or bony).\n* Patients with psychiatric disease or substance abuse or have an allergy to the substance used in the study.'}, 'identificationModule': {'nctId': 'NCT06205667', 'briefTitle': 'Computer Guided Versus Conventional Arthrocentesis in Management of Internal Derangements: A Randomized Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Computer Guided Versus Conventional Arthrocentesis in Management of Internal Derangements: A Randomized Clinical Study', 'orgStudyIdInfo': {'id': 'FD-ASU-RCC.IM022204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Computer Guided Arthrocentesis', 'description': 'a study group injected intra-articularly through TMJ using a computer-guided template.', 'interventionNames': ['Procedure: Computer Guided Arthrocentesis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Arthrocentesis', 'description': 'a control group which injected intra-articular through TMJ using conventional method based on anatomical landmark determination', 'interventionNames': ['Procedure: Conventional Arthrocentesis']}], 'interventions': [{'name': 'Computer Guided Arthrocentesis', 'type': 'PROCEDURE', 'description': 'patients are going to be injected intra-articular within the superior joint space of the affected TMJ through custom guided template planned in a manner inspired by earphone design to get support from the tragus.', 'armGroupLabels': ['Computer Guided Arthrocentesis']}, {'name': 'Conventional Arthrocentesis', 'type': 'PROCEDURE', 'description': 'patients are going to be injected intra-articular within the superior joint space of the affected TMJ using conventional method anatomical landmark determination', 'armGroupLabels': ['Conventional Arthrocentesis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ainshams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}