Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
Study NCT ID:
NCT03675659
Status:
UNKNOWN
Last Update Posted:
2018-09-21
First Post:
2018-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intra-articular Magnesium Sulfate for Tmj Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007270', 'term': 'Injections, Intra-Articular'}, {'id': 'D000075527', 'term': 'Prolotherapy'}], 'ancestors': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000529', 'term': 'Complementary Therapies'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-20', 'studyFirstSubmitDate': '2018-09-15', 'studyFirstSubmitQcDate': '2018-09-17', 'lastUpdatePostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'estimation of pain: Visual Analog Scale', 'timeFrame': 'one year', 'description': 'Visual Analog Scale pain measurement with "0" indicates no pain and "100" the maximum pain felt ever'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tmj pain'], 'conditions': ['Temporomandibular Joint Disorders', 'Temporomandibular Sprain']}, 'descriptionModule': {'briefSummary': 'mixing the magnesium sulfate with dextrose for management of tmj pain will be studied using intra-articular injection of the solution'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'females more affected than males', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy females-no treatment received within the last 6 months-accept treatment protocol\n\nExclusion Criteria:\n\n* unco-operative patients-patients with auto-immune diseases-patients diagnosed with arthritis'}, 'identificationModule': {'nctId': 'NCT03675659', 'briefTitle': 'Intra-articular Magnesium Sulfate for Tmj Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Magnesium Sulfate on Pain and Clicking Sound on Patients With Temporomandibular Joint Dysfunction', 'orgStudyIdInfo': {'id': 'CD5618'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intra-articular injection', 'description': 'intra-articular injection with magnesium sulfate at weekly interval for four weeks', 'interventionNames': ['Drug: intra-articular injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'intra-articular injection with saline', 'interventionNames': ['Drug: intra-articular injection']}], 'interventions': [{'name': 'intra-articular injection', 'type': 'DRUG', 'otherNames': ['prolotherapy'], 'description': 'intra-articular injection with magnesium sulfate with four injections at weekly intervals', 'armGroupLabels': ['control', 'intra-articular injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12111', 'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'atef fouda, prof', 'role': 'CONTACT', 'phone': '01224316042'}], 'facility': 'Atef', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Atef A fouda, prof', 'role': 'CONTACT', 'email': 'atef.fouda@dentistry.cu.edu.eg', 'phone': '01093440600', 'phoneExt': '002'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof of maxillofacial surgery', 'investigatorFullName': 'Atef Fouda', 'investigatorAffiliation': 'Cairo University'}}}}