Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-01-09 @ 8:53 PM
Study NCT ID:
NCT06573502
Status:
COMPLETED
Last Update Posted:
2025-12-12
First Post:
2024-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet Rich Plasma Combined With Platelet Rich Fibrin in Management of Temporomandibular Joint Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D051219', 'term': 'Pituitary Adenylate Cyclase-Activating Polypeptide'}, {'id': 'D056690', 'term': 'Prolactin-Releasing Hormone'}], 'ancestors': [{'id': 'D009414', 'term': 'Nerve Growth Factors'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2024-07-31', 'studyFirstSubmitQcDate': '2024-08-23', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain severty', 'timeFrame': '6 months', 'description': 'Visual analog scale measure for pain most sever pain take 10 minimum pain take 0'}], 'secondaryOutcomes': [{'measure': 'Maximum mouth opening', 'timeFrame': '6 months', 'description': 'Measured with calipar'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Studying effectiveness of prp with prf comparing with prp or prf for mangement of tmj osteoarthritis as result in pain and mandibular movement in adult pt', 'detailedDescription': '45 pt assigned for the study , divided in to three gruops to comparing new combination of prp with prf in management of TMJ OA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult pt with OA\n\nExclusion Criteria:\n\nMedicaly compromised'}, 'identificationModule': {'nctId': 'NCT06573502', 'briefTitle': 'Platelet Rich Plasma Combined With Platelet Rich Fibrin in Management of Temporomandibular Joint Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Assessment of Platelet Rich Plasma With Injectable Platelet Rich Fibrin VS Platelet Rich Plasma Vs Platelet Rich Fibrin in Management of Temporomandibular Joint Osteoarthritis', 'orgStudyIdInfo': {'id': 'Not selected'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'prp with prf group', 'description': 'Pt will recievd prp with prf', 'interventionNames': ['Combination Product: Prp with prf or prp or prf']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'prp group', 'description': 'Pt will recieve prp only', 'interventionNames': ['Combination Product: Prp with prf or prp or prf']}, {'type': 'EXPERIMENTAL', 'label': 'prf group', 'description': 'Pt will recieve prf only', 'interventionNames': ['Combination Product: Prp with prf or prp or prf']}], 'interventions': [{'name': 'Prp with prf or prp or prf', 'type': 'COMBINATION_PRODUCT', 'description': 'Combination', 'armGroupLabels': ['prf group', 'prp group', 'prp with prf group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Hassan Ab Ghany, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aliaa Babekir Ahmed Mohamed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Aliaa Babekir Ahmed Mohamed', 'investigatorAffiliation': 'Cairo University'}}}}