Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT03408418
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2018-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
L-PRF in Alveolar Ridge Preservation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016301', 'term': 'Alveolar Bone Loss'}], 'ancestors': [{'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-25', 'studyFirstSubmitDate': '2018-01-16', 'studyFirstSubmitQcDate': '2018-01-22', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Width resorption 1mm', 'timeFrame': 'After 3 months', 'description': 'The ridge width differences between baseline and after three months of healing 1 mm below the crest.'}], 'secondaryOutcomes': [{'measure': 'Width resorption 3mm', 'timeFrame': 'After 3 months', 'description': 'The ridge width differences between baseline and after three months of healing 3 mm below the crest.'}, {'measure': 'Width resorption 5mm', 'timeFrame': 'After 3 months', 'description': 'The ridge width differences between baseline and after three months of healing 5 mm below the crest.'}, {'measure': 'Histological Analysis - fibrous tissue', 'timeFrame': 'After 3 months', 'description': 'The percentage of soft (fibrous) tissue'}, {'measure': 'Histological Analysis - bone cells', 'timeFrame': 'After 3 months', 'description': 'Quantity of bone cells (osteoblast, osteoclast and osteocyte)'}, {'measure': 'Histological Analysis - capillary vessels', 'timeFrame': 'After 3 months', 'description': 'Quantity of capillary vessels'}, {'measure': 'Histological Analysis - new bone formation', 'timeFrame': 'After 3 months', 'description': 'The percentage of the newly formed bone'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Platelet-rich fibrin', 'Tooth Extraction', 'Alveolar Bone Grafting'], 'conditions': ['Bone Loss, Alveolar']}, 'referencesModule': {'references': [{'pmid': '31810848', 'type': 'DERIVED', 'citation': 'Canellas JVDS, da Costa RC, Breves RC, de Oliveira GP, Figueredo CMDS, Fischer RG, Thole AA, Medeiros PJD, Ritto FG. Tomographic and histomorphometric evaluation of socket healing after tooth extraction using leukocyte- and platelet-rich fibrin: A randomized, single-blind, controlled clinical trial. J Craniomaxillofac Surg. 2020 Jan;48(1):24-32. doi: 10.1016/j.jcms.2019.11.006. Epub 2019 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'The effect of leucocyte- and platelet-rich fibrin (L-PRF) for enhancing the healing after dental extractions is still a matter of debate. The available literature suggests that L-PRF performs positive effect to improve alveolar preservation resulting in less bone resorption on extraction sockets. L-PRF is a second generation of platelet concentrate produced without biochemical blood manipulation. L-PRF is composed by three key parameters: first, the presence of platelets; second, the presence of leucocytes; third, the density and complex organization of the fibrin matrix architecture produced by a natural polymerization process. The theory is that this key parameters acts to produce a faster bone healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) Health patients, American Society of Anesthesiologists (ASA) I or II\n* (2) Patients who need to submit tooth extraction (pre-molar, canine and incisor teeth - uniradicular teeth or teeth with fused roots) which present ideal conditions to receive dental implants after 3 months.\n\nExclusion Criteria:\n\n* Smoking\n* Systemic diseases related with healing disorders\n* Poor oral hygiene\n* Pregnant or lactating patient\n* Use of flap elevation for dental extraction'}, 'identificationModule': {'nctId': 'NCT03408418', 'acronym': 'L-PRF', 'briefTitle': 'L-PRF in Alveolar Ridge Preservation', 'organization': {'class': 'OTHER', 'fullName': 'Rio de Janeiro State University'}, 'officialTitle': 'Tomographic and Histological Evaluation of Postextraction Sockets Treated With Leucocyte- and Platelet-rich Fibrin: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '72596717.3.0000.5259'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L-PRF group', 'description': 'The use of autologous leucocyte- and platelet-rich fibrin in alveolar sockets after dental extraction.', 'interventionNames': ['Procedure: Platelet-rich fibrin']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Conventional tooth extraction without any bone substitute.'}], 'interventions': [{'name': 'Platelet-rich fibrin', 'type': 'PROCEDURE', 'otherNames': ['platelet concentrate'], 'description': 'The use of autologous platelet-rich fibrin after tooth extraction to promote bone healing and alveolar ridge preservation', 'armGroupLabels': ['L-PRF group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20551-030', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Rio de Janeiro State University', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'João Canellas, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rio de Janeiro State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rio de Janeiro State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'João Vitor dos Santos Canellas, DDS MS', 'investigatorAffiliation': 'Rio de Janeiro State University'}}}}