Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:46 AM
Study NCT ID:
NCT07078006
Status:
COMPLETED
Last Update Posted:
2025-07-22
First Post:
2024-12-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Injectable Platelet Rich Fibrin Versus Platelet Rich Plasma Injection in Degenerative Temporomandibular Joint
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-12', 'studyFirstSubmitDate': '2024-12-31', 'studyFirstSubmitQcDate': '2025-07-12', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain improvement', 'timeFrame': '6 months post-procedure', 'description': 'Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS was recorded preoperatively, immediately after the procedures, 1 month, 3 months, and 6 months postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Assessment of tissue repair', 'timeFrame': '6 months post-procedure', 'description': 'Tissue repair in the form of initiating fibrin coating around the osteoarthritic joint by using Magnetic Resonance Imaging (MRI) was recorded.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Platelet Rich Fibrin', 'Platelet Rich Plasma Injection', 'Degenerative Temporomandibular Joint']}, 'descriptionModule': {'briefSummary': 'The study aimed to compare the efficacy of injectable platelet rich fibrin (I-PRF) versus platelet rich plasma (PRP) injection in degenerative temporomandibular joint (TMJ).', 'detailedDescription': 'Degenerative joint disease (DJD), a frequently observed as osteoarthritic condition in clinical practice, manifests as a persistent and continuous transformation in joint configuration due to the deterioration and attrition of articular cartilage, accompanied by modifications in the subchondral bone and other soft tissue.\n\nTreatment includes physical therapy, pulsed electrical stimulation, pharmacological, topical ointments, supplements, steroid injections, hyaluronic acid (HA) injections, and acupuncture.\n\nFurther studies have been carried out to better investigate the effectiveness of different techniques to perform arthrocentesis by using growth factors, autologous solutions, or alternative materials; the materials most used are platelet-rich plasma (PRP) and HA in arthrocentesis or by injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years old.\n* Both sexes.\n* Patients with unilateral or bilateral temporomandibular joint (TMJ) osteoarthritis according to magnetic resonance imaging (MRI) evaluation.\n\nExclusion Criteria:\n\n* Patients under any type of antiplatelet or anticoagulant medications.\n* Cardiovascular, renal, or hepatic disease.\n* Diabetes.\n* Anemia.\n* Vascular insufficiency.\n* Peripheral neuropathy.\n* Previous surgery for TMJ and rheumatoid arthritis.'}, 'identificationModule': {'nctId': 'NCT07078006', 'briefTitle': 'Injectable Platelet Rich Fibrin Versus Platelet Rich Plasma Injection in Degenerative Temporomandibular Joint', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Nasser Institute For Research and Treatment'}, 'officialTitle': 'Efficacy of Injectable Platelet Rich Fibrin Versus Platelet Rich Plasma Injection in Degenerative Temporomandibular Joint', 'orgStudyIdInfo': {'id': '55653465'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'Patients underwent arthrocentesis followed by a platelet-rich fibrin (PRF) injection using a conventional temporomandibular joint (TMJ) injection technique, aided by facial anatomical landmarks.', 'interventionNames': ['Other: Platelet Rich Fibrin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II', 'description': 'Patients underwent arthrocentesis followed by a platelet-rich plasma (PRP) injection using a conventional temporomandibular joint (TMJ) injection technique, aided by facial anatomical landmarks.', 'interventionNames': ['Other: Platelet Rich Plasma']}], 'interventions': [{'name': 'Platelet Rich Fibrin', 'type': 'OTHER', 'description': 'Patients underwent arthrocentesis followed by a platelet-rich fibrin (PRF) injection using a conventional temporomandibular joint (TMJ) injection technique, aided by facial anatomical landmarks.', 'armGroupLabels': ['Group I']}, {'name': 'Platelet Rich Plasma', 'type': 'OTHER', 'description': 'Patients underwent arthrocentesis followed by a platelet-rich plasma (PRP) injection using a conventional temporomandibular joint (TMJ) injection technique, aided by facial anatomical landmarks.', 'armGroupLabels': ['Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112345', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Nasser', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nasser Institute For Research and Treatment', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Oral and Maxillofacial Surgery Department, Faculty of Oral & Dental Medicine, AL Azhar University, Assuit, Egypt.', 'investigatorFullName': 'Omar Samir', 'investigatorAffiliation': 'Nasser Institute For Research and Treatment'}}}}