Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-31 @ 12:22 PM
Study NCT ID:
NCT04731233
Status:
TERMINATED
Last Update Posted:
2025-02-21
First Post:
2021-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of PRGF Supplementation After TMJ Arthrocentesis in Patients With TMJ Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}}}}, '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': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'widmer@dental.ufl.edu', 'phone': '352-273-5696', 'title': 'Dr. Charles G. Widmer', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Due to the limited number of participants in this clinical trial, the study was terminated, and a statistical analysis was not conducted.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'PRGF Arm', 'description': "The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nPlasma Rich in Growth Factor (PRGF) Supplementation: After rinsing the joint, the TMJ will be injected with blood plasma rich in growth factors (PRGF). PRGF supplementation which is an autologous platelet-enriched plasma obtained from patient's own blood, which after activation with calcium chloride allows the release of a pool of biologically active proteins that influence and promote a range of biological processes.", 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Steroid Arm', 'description': 'Two cc containing 40 mg of triamcinolone acetonide with 5 mg bupivacaine will be infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nTriamcinolone Acetonide: After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRGF Arm', 'description': "The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nPlasma Rich in Growth Factor (PRGF) Supplementation: After rinsing the joint, the TMJ will be injected with blood plasma rich in growth factors (PRGF). PRGF supplementation which is an autologous platelet-enriched plasma obtained from patient's own blood, which after activation with calcium chloride allows the release of a pool of biologically active proteins that influence and promote a range of biological processes."}, {'id': 'OG001', 'title': 'Steroid Arm', 'description': 'Two cc containing 40 mg of triamcinolone acetonide with 5 mg bupivacaine will be infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nTriamcinolone Acetonide: After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'spread': '50.0', 'groupId': 'OG000'}, {'value': '90.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Three Months', 'description': 'The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRGF Arm', 'description': "The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nPlasma Rich in Growth Factor (PRGF) Supplementation: After rinsing the joint, the TMJ will be injected with blood plasma rich in growth factors (PRGF). PRGF supplementation which is an autologous platelet-enriched plasma obtained from patient's own blood, which after activation with calcium chloride allows the release of a pool of biologically active proteins that influence and promote a range of biological processes."}, {'id': 'OG001', 'title': 'Steroid Arm', 'description': 'Two cc containing 40 mg of triamcinolone acetonide with 5 mg bupivacaine will be infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nTriamcinolone Acetonide: After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '80.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six Months', 'description': 'The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Chewing Pain Measured by Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRGF Arm', 'description': "The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nPlasma Rich in Growth Factor (PRGF) Supplementation: After rinsing the joint, the TMJ will be injected with blood plasma rich in growth factors (PRGF). PRGF supplementation which is an autologous platelet-enriched plasma obtained from patient's own blood, which after activation with calcium chloride allows the release of a pool of biologically active proteins that influence and promote a range of biological processes."}, {'id': 'OG001', 'title': 'Steroid Arm', 'description': 'Two cc containing 40 mg of triamcinolone acetonide with 5 mg bupivacaine will be infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nTriamcinolone Acetonide: After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.25', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '78.6', 'spread': '10.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Chewing Pain Measured by Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRGF Arm', 'description': "The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nPlasma Rich in Growth Factor (PRGF) Supplementation: After rinsing the joint, the TMJ will be injected with blood plasma rich in growth factors (PRGF). PRGF supplementation which is an autologous platelet-enriched plasma obtained from patient's own blood, which after activation with calcium chloride allows the release of a pool of biologically active proteins that influence and promote a range of biological processes."}, {'id': 'OG001', 'title': 'Steroid Arm', 'description': 'Two cc containing 40 mg of triamcinolone acetonide with 5 mg bupivacaine will be infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nTriamcinolone Acetonide: After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.25', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '42', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six Months', 'description': 'The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Temporomandibular Joint Crepitus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRGF Arm', 'description': "The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nPlasma Rich in Growth Factor (PRGF) Supplementation: After rinsing the joint, the TMJ will be injected with blood plasma rich in growth factors (PRGF). PRGF supplementation which is an autologous platelet-enriched plasma obtained from patient's own blood, which after activation with calcium chloride allows the release of a pool of biologically active proteins that influence and promote a range of biological processes."}, {'id': 'OG001', 'title': 'Steroid Arm', 'description': 'Two cc containing 40 mg of triamcinolone acetonide with 5 mg bupivacaine will be infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nTriamcinolone Acetonide: After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Presence of multiple, distinct joint sounds (crepitus).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Temporomandibular Joint Crepitus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRGF Arm', 'description': "The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nPlasma Rich in Growth Factor (PRGF) Supplementation: After rinsing the joint, the TMJ will be injected with blood plasma rich in growth factors (PRGF). PRGF supplementation which is an autologous platelet-enriched plasma obtained from patient's own blood, which after activation with calcium chloride allows the release of a pool of biologically active proteins that influence and promote a range of biological processes."}, {'id': 'OG001', 'title': 'Steroid Arm', 'description': 'Two cc containing 40 mg of triamcinolone acetonide with 5 mg bupivacaine will be infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nTriamcinolone Acetonide: After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine.'}], 'classes': [{'categories': [{'title': 'TMJ Crepitus Present', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No TMJ Sound', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Six Months', 'description': 'Presence of multiple, distinct joint sounds (crepitus).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PRGF Arm', 'description': "The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nPlasma Rich in Growth Factor (PRGF) Supplementation: After rinsing the joint, the TMJ will be injected with blood plasma rich in growth factors (PRGF). PRGF supplementation which is an autologous platelet-enriched plasma obtained from patient's own blood, which after activation with calcium chloride allows the release of a pool of biologically active proteins that influence and promote a range of biological processes."}, {'id': 'FG001', 'title': 'Steroid Arm', 'description': 'Two cc containing 40 mg of triamcinolone acetonide with 5 mg bupivacaine will be infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nTriamcinolone Acetonide: After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment period: 02-17-2021 to 02-21-2024 Study location: Oral and Maxillofacial Surgery Clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PRGF Arm', 'description': "The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nPlasma Rich in Growth Factor (PRGF) Supplementation: After rinsing the joint, the TMJ will be injected with blood plasma rich in growth factors (PRGF). PRGF supplementation which is an autologous platelet-enriched plasma obtained from patient's own blood, which after activation with calcium chloride allows the release of a pool of biologically active proteins that influence and promote a range of biological processes."}, {'id': 'BG001', 'title': 'Steroid Arm', 'description': 'Two cc containing 40 mg of triamcinolone acetonide with 5 mg bupivacaine will be infused into the upper joint space after the TMJ arthrocentesis procedure.\n\nTriamcinolone Acetonide: After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Temporomandibular Joint (TMJ) Intracapsular Pain-Visual Analog Scale (VAS) Rating', 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'spread': '27.5', 'groupId': 'BG000'}, {'value': '90.0', 'spread': '0.0', 'groupId': 'BG001'}, {'value': '78.6', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-01-02', 'size': 83642, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-06T12:46', 'hasProtocol': True}, {'date': '2025-01-02', 'size': 80702, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-06T12:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Could not recruit participants due to their refusal to be randomized in the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2021-01-26', 'resultsFirstSubmitDate': '2025-01-06', 'studyFirstSubmitQcDate': '2021-01-28', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-20', 'studyFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Chewing Pain Measured by Visual Analog Scale (VAS)', 'timeFrame': 'Baseline', 'description': 'The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain).'}, {'measure': 'Chewing Pain Measured by Visual Analog Scale (VAS)', 'timeFrame': 'Six Months', 'description': 'The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain).'}, {'measure': 'Temporomandibular Joint Crepitus', 'timeFrame': 'Baseline', 'description': 'Presence of multiple, distinct joint sounds (crepitus).'}, {'measure': 'Temporomandibular Joint Crepitus', 'timeFrame': 'Six Months', 'description': 'Presence of multiple, distinct joint sounds (crepitus).'}], 'primaryOutcomes': [{'measure': 'Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating', 'timeFrame': 'Three Months', 'description': 'The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain).'}, {'measure': 'Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating', 'timeFrame': 'Six Months', 'description': 'The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TMJ', 'Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Temporomandibular joint (TMJ) osteoarthritis (OA) affects articulating tissues secondary to inflammation resulting in intracapsular pain. This prospective, double-blind randomized clinical trial will evaluate the relative efficacy of TMJ arthrocentesis with a supplementation of platelet-rich growth factors (PRGF) compared to TMJ arthrocentesis with a steroid supplementation (a known effective therapy) for patients with TMJ OA.', 'detailedDescription': "Temporomandibular disorders (TMD) are musculoskeletal disorders that are commonly encountered, with pain in the temporomandibular joint (TMJ) and jaw closing muscles. Pain that involves the temporomandibular joint includes inflammatory pathologies such as arthritides, painful disk displacements and many times have an overlay of psychosocial comorbidities due to the uncontrolled pain. TMJ osteoarthritis is an intracapsular condition affecting the temporomandibular joint and presents with remodeling of the TMJ articulating tissues including the condyle and articular eminence secondary to inflammation resulting in intracapsular pain. There is a paucity of information regarding the relative effectiveness of different therapies for the treatment of patients with TMJ osteoarthritis. The identification of the least invasive and most efficacious therapy is vital to proper management of these patients with temporomandibular joint pain and disability. The purpose of this study is to establish the relative efficacy of TMJ arthrocentesis with steroid supplementation (a known effective therapy) compared to TMJ arthrocentesis with a supplement of plasma rich in growth factors (PRGF) for patients with TMJ osteoarthritis. Plasma rich in growth factors is isolated from the patient's own blood and injected into the temporomandibular joint to activate stem cells that may restore some of the articulating tissues that were lost during degeneration changes within the joint secondary to osteoarthritis. Pain and disability will be assessed using standard pain and physical measures that are recorded before and after treatment. Patients enrolled into the study will be examined and treated at the Department of Oral and Maxillofacial Surgery Faculty/Resident clinic. At the first appointment, they will be examined following standard procedures (medical history, physical exam, imaging by cone beam computerized tomography (CBCT)) to determine their diagnosis(es) and if they would potentially benefit from the TMJ arthrocentesis procedure. If the patient meets the inclusion criteria for the study and with their informed consent on the day of their TMJ arthrocentesis procedure, they will be required to have a pregnancy test if below age 60 and complete a questionnaire about their physical and pain symptoms and undergo a standardized clinical exam. The patients will then undergo the standard clinical protocol for TMJ arthrocentesis followed by either a 2 cc steroid/bupivacaine hydrochloride supplementation (standard treatment group) or a 2 cc PRGF supplementation (experimental group) into the TMJ. Follow-up appointments will be conducted at 1 month, 3 months and 6 months when the pain VAS measures and a clinical exam will be assessed. If patients have not experienced improvement in their primary outcome measure (TMJ pain) at the 3 month evaluation, the patient will have a second TMJ arthrocentesis procedure that will be supplemented with the alternative medication/growth factors (steroid or PRGF) using a cross-over design. Data from these patients will be analyzed separately from patients that complete the six month study. Also at 6 months, a second CBCT image of the temporomandibular joints will be obtained to determine the extent of bone remodeling within the TMJ. The results of this study should provide new information on the efficacy of PRGF supplementation for management of temporomandibular joint osteoarthritis."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'Only females will be studied since greater than 95% of the patients that pursue temporomandibular joint arthrocentesis are female.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* 40 - 80 years of age\n* Unilateral or bilateral TMJ arthralgia\n* Osteoarthritis diagnosis according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)\n* TMJ sounds (crepitus or click or both)\n* Mild-moderate masticatory muscle myalgia\n* History of non-surgical treatment for at least 6 weeks including such modalities as appliance therapy, NSAID therapy or physical modalities without resolution of pain\n\nExclusion Criteria:\n\n* Contraindication to sedation including pregnancy or medical history\n* Rheumatologic disorders causing arthritis of the temporomandibular joint (i.e., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis)\n* History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy\n* History of steroid injection in TMJ\n* TMJ pain greater than five years\n* History of narcotic drug use on a scheduled basis\n* Current active infection\n* Fibromyalgia'}, 'identificationModule': {'nctId': 'NCT04731233', 'briefTitle': 'Efficacy of PRGF Supplementation After TMJ Arthrocentesis in Patients With TMJ Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'A Randomized, Double-Blind Study of the Efficacy of Platelet-Rich Growth Factor (PRGF) Supplementation Compared to Steroid Supplementation After Temporomandibular Joint (TMJ) Arthrocentesis in Female Patients With TMJ Osteoarthritis (OA)', 'orgStudyIdInfo': {'id': 'IRB202000689-A'}, 'secondaryIdInfos': [{'id': 'OCR40106', 'type': 'OTHER', 'domain': 'UF OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRGF Arm', 'description': 'The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure.', 'interventionNames': ['Biological: Plasma Rich in Growth Factor (PRGF) Supplementation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Steroid Arm', 'description': 'Two cc containing 40 mg of triamcinolone acetonide with 5 mg bupivacaine will be infused into the upper joint space after the TMJ arthrocentesis procedure.', 'interventionNames': ['Drug: Triamcinolone Acetonide']}], 'interventions': [{'name': 'Plasma Rich in Growth Factor (PRGF) Supplementation', 'type': 'BIOLOGICAL', 'description': "After rinsing the joint, the TMJ will be injected with blood plasma rich in growth factors (PRGF). PRGF supplementation which is an autologous platelet-enriched plasma obtained from patient's own blood, which after activation with calcium chloride allows the release of a pool of biologically active proteins that influence and promote a range of biological processes.", 'armGroupLabels': ['PRGF Arm']}, {'name': 'Triamcinolone Acetonide', 'type': 'DRUG', 'otherNames': ['Kenalog'], 'description': 'After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine.', 'armGroupLabels': ['Steroid Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Charles G. Widmer, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}