Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT04022720
Status:
WITHDRAWN
Last Update Posted:
2020-08-06
First Post:
2019-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No patients enrolled. Also, impacted of COVID on enrolling subjects hindered recruitment.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-04', 'studyFirstSubmitDate': '2019-07-12', 'studyFirstSubmitQcDate': '2019-07-16', 'lastUpdatePostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in rate of healing in intraoral mucosa and epithelium soft tissues', 'timeFrame': '3 months post-operatively', 'description': 'Improved healing times of PRF patients compared to control group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['platelet rich fibrin (PRF)'], 'conditions': ['Mucosal Ulceration']}, 'descriptionModule': {'briefSummary': 'Determine if the use of platelet rich fibrin (PRF) improves the rate and quality of healing for intraoral mucosal and epithelial soft tissue defects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Three categories of patients will be included in this study:\n\n 1. Osteoradionecrosis (ORN) or medication related osteonecrosis of the jaw (MRONJ) patients who present to clinic with exposed bone and no clinical sign of infection.\n 2. Patients having an excisional biopsy in clinic performed under local anesthesia resulting in a defect that cannot be easily repaired without compromising normal anatomy or function. These situations include excisions which would result in primary closure under tension or with distorted anatomy, require a local flap, or require healing by secondary intention.\n 3. Patients presenting to the post-operative clinic with intraoral surgical wound dehiscence or an intraoral surgical wound healing by secondary intention.\n\n Exclusion Criteria:\n* Patients under 18 years of age.\n* Patient's unable to participate in blood draw either due to medical compromise, inability to tolerate the procedure, or inability of the physician to successfully draw the blood at the time of appointment."}, 'identificationModule': {'nctId': 'NCT04022720', 'briefTitle': 'Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Role of Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration of Head and Neck Surgery Patients: A Prospective Clinical Trial', 'orgStudyIdInfo': {'id': 'IRB201901614'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platelet Rich Fibrin (PRF) Group', 'description': 'Patients randomized to this group will receive treatment with a PRF graft.', 'interventionNames': ['Procedure: Platelet Rich Fibrin Application']}, {'type': 'NO_INTERVENTION', 'label': 'No Platelet Rich Fibrin Group', 'description': 'Participants in the observational control group will be managed at the time of the complication by standard of care methods.'}], 'interventions': [{'name': 'Platelet Rich Fibrin Application', 'type': 'PROCEDURE', 'description': 'Platelet Rich Fibrin application at first post-op visit.', 'armGroupLabels': ['Platelet Rich Fibrin (PRF) Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Salam Salman, MD, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD will be shared with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}