Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT05882604
Status:
COMPLETED
Last Update Posted:
2025-07-24
First Post:
2023-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MESNA Injection for TMJ Internal Derangement
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': 'D015080', 'term': 'Mesna'}, {'id': 'D000069237', 'term': 'Arthrocentesis'}, {'id': 'D000077331', 'term': "Ringer's Solution"}], 'ancestors': [{'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D019152', 'term': 'Paracentesis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-20', 'studyFirstSubmitDate': '2023-05-22', 'studyFirstSubmitQcDate': '2023-05-22', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximal interincisal opening (MIO)', 'timeFrame': '6 months', 'description': 'a digital caliper will be employed to measure the maximum interincisal opening pre and postoperative'}], 'secondaryOutcomes': [{'measure': 'Joint pain', 'timeFrame': '6 months', 'description': 'pain will be assessed on a visual analogue scale (VAS) with a score between 0 and 10, 0 means no pain and 10 means severe pain'}, {'measure': 'clicking sound', 'timeFrame': '6 months', 'description': 'yes or no questionnaire,yes mean clicking is present and no means clicking disappeared'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TMJ Disorder']}, 'descriptionModule': {'briefSummary': 'The pathogenesis of temporomandibular disorders focusing on the biochemistry of the synovial fluid in various stages of temporomandibular joint disease. The role of inflammation has been investigated and proposed as an underlying mechanism of pain and dysfunction of temporomandibular joint. MESNA (sodium 2-mercaptoethanesulfonate) was approved several years ago and marketed in several formulations as a mucolytic agent in the respiratory field, since it breaks the disulfide bonds between polypeptide chains of mucus. The tissue distribution of MESNA is negligible, and the elimination of the substance is rapidly and completely achieved by kidney', 'detailedDescription': 'Clarification (July 2025): Recruitment was completed in March 2023 following clinical scheduling and preliminary departmental clearance, while formal written ethical approval was finalized in early April 2023. All patients were followed up for one year, and the study was completed by March 2024.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with TMJ internal derangement with reduction\n\nExclusion Criteria:\n\n* inflammatory or connective tissue disease\n* autoimmune disease history\n* neurologic problems'}, 'identificationModule': {'nctId': 'NCT05882604', 'briefTitle': 'MESNA Injection for TMJ Internal Derangement', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Treatment of Temporomandibular Joint Internal Derangement Using MESNA Injection', 'orgStudyIdInfo': {'id': '#R-OS-4-23-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intra-articular injection with MESNA solution', 'description': '1 ml of MESNA will be injected intra-articular', 'interventionNames': ['Drug: Mesna Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arthrocentesis with ringer solution', 'description': 'ringer solution will be used for arthrocentesis', 'interventionNames': ['Drug: Arthrocentesis with ringer solution']}], 'interventions': [{'name': 'Mesna Injection', 'type': 'DRUG', 'description': '1 ml of MESNA will be injected using 20-guage needle in he upper compartment of TMJ in patient with internal derrangement.', 'armGroupLabels': ['Intra-articular injection with MESNA solution']}, {'name': 'Arthrocentesis with ringer solution', 'type': 'DRUG', 'description': "Two 20-gauge needles will be placed into upper joint space as entry and exit points for washing.The arthrocentesis will be performed with 100 ml of lactated Ringer's solution to eliminate the inflammatory mediators present in the synovial fluid", 'armGroupLabels': ['Arthrocentesis with ringer solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6624033', 'city': 'Tanta', 'state': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of oral and maxillofacial surgery', 'investigatorFullName': 'Ahmed Abdellatif Abdelfatah', 'investigatorAffiliation': 'Tanta University'}}}}