Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-03-30 @ 7:37 PM
Study NCT ID:
NCT06345092
Status:
COMPLETED
Last Update Posted:
2024-11-08
First Post:
2024-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between IPRF With Vit. C and IPRF Alone in Management of ID'Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2024-04-01', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'maximum mouth opening', 'timeFrame': 'at 4;8;12;16 weeks', 'description': 'measurement of MMO using digital caliper pre and post injections'}, {'measure': 'lateral excursion', 'timeFrame': 'at 4;8;12;16 weeks', 'description': 'measurement of lateral excursion using digital caliper pre and post injections'}], 'primaryOutcomes': [{'measure': 'Pain management', 'timeFrame': 'at 4;8;12;16 weeks', 'description': 'Evaluation of pain using VAS pre and post injections'}], 'secondaryOutcomes': [{'measure': 'disc position using MRI', 'timeFrame': 'at 4;8;12;16 weeks', 'description': 'evaluation of disc position pre and post injections'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TMJ Pain']}, 'descriptionModule': {'briefSummary': 'Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement', 'detailedDescription': 'Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with internal TMJ derangement (anterior disc displacement with reduction)\n\nExclusion Criteria:\n\nPathological conditions ; trauma TMJ cases or any blood diseases'}, 'identificationModule': {'nctId': 'NCT06345092', 'briefTitle': "Comparison Between IPRF With Vit. C and IPRF Alone in Management of ID'Pain", 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': "Comparison Between Injectable Platelet Rich Fibrin With Vitamin C and Injectable Platelet Rich Fibrin Alone in Management of ID'Pain", 'orgStudyIdInfo': {'id': 'Omfs.3-3-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'injection of injectable platelet rich fibrin with vitamin C', 'interventionNames': ['Drug: Vitamin C', 'Other: Injectable platelet rich fibrin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'injection of injectable platelet rich fibrin alone', 'interventionNames': ['Other: Injectable platelet rich fibrin']}], 'interventions': [{'name': 'Vitamin C', 'type': 'DRUG', 'otherNames': ['Ascorbic acid'], 'description': 'addition of vitamin C to IPRF', 'armGroupLabels': ['intervention group']}, {'name': 'Injectable platelet rich fibrin', 'type': 'OTHER', 'otherNames': ['IPRF'], 'description': 'injection of IPRF alone', 'armGroupLabels': ['control group', 'intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+2', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc degree of oral and maxillofacial surgery Cairo University', 'investigatorFullName': 'Youmna alaa yehia', 'investigatorAffiliation': 'Cairo University'}}}}