Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-01 @ 4:43 PM
Study NCT ID:
NCT04224935
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2020-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of (L-PRF) Membrane in The Treatment of Gingival Recession
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-03', 'size': 910098, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-11-03T07:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2020-01-01', 'studyFirstSubmitQcDate': '2020-01-09', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recession treatment', 'timeFrame': '9 months', 'description': '2-Esthetic outcome evaluation was done using Root coverage esthetic score (RES) system ( Cairo et al. 2009) the RES include the following parameters\n\n• Level of the gingival margin (GM):(minimum) Zero points = failure of root coverage (gingival margin apical or equal to the baseline recession); 3 points = partial root coverage;(maximum) 6 points = CRC.'}], 'secondaryOutcomes': [{'measure': 'soft tissue thickness (Volumetric assessment)', 'timeFrame': '9 months', 'description': 'Preoperatively a cast was made and scanned. At 9 months after surgical procedure the same procedure was done to determine the soft tissue thickness after the surgery. The difference between the tissue thickness before and after was used to determine the efficacy of the different surgical grafting materials used.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Localized Gingival Recession']}, 'descriptionModule': {'briefSummary': 'evaluation of the use of L-PRF membrane with coronally repositioned flap in treatment of localized gingival recession (Class I \\& II) in comparison with the use of connective tissue graft', 'detailedDescription': 'Twenty patients, who are candidates for gingival recession coverage, will participate in this prospective clinical trial.\n\nGroup 1(10 patients) :\n\nCoronally repositioned flap will be done and L PRF membrane will be placed into the tissues\n\nGroup 2 (Control group)(10 patients) :\n\nCoronally repositioned flap will be done with sub epithelial connective tissue Parameters\n\n* Clinical evaluation of percentage of root coverage and keratinized tissue width\n* Esthetic outcome evaluation Will be done using the root coverage esthetic score (Cairo et al. 2009) that include\n\nBoth evaluations will be done at 3, 6 and 9 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemically free patients (American Society of Anesthesiologists I; ASA I).\n* Age range (20 -40) years.\n* Good compliance with the plaque control instructions following initial therapy.\n* Patients diagnosed with Miller class I or II in anterior and premolar teeth\n* Availability for follow up and maintenance program.\n\nExclusion Criteria:\n\n* Patient suffering from periodontitis\n* Presence of smoking habit.\n* Presence of occlusion interference.\n* Pregnant and lactating females.\n* Vulnerable group of patients (handicapped, mentally retarded and prisoners).'}, 'identificationModule': {'nctId': 'NCT04224935', 'briefTitle': 'The Effect of (L-PRF) Membrane in The Treatment of Gingival Recession', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Effect of Leukocyte Platelet Rich Fibrin(L-PRF) Membrane in The Treatment of Localized Gingival Recession (Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': '453'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Leukocyte Platelet Rich Fibrin', 'description': 'Leukocyte Platelet Rich Fibrin will be used', 'interventionNames': ['Procedure: Leukocyte Platelet rich fibrin membrane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'connective tissue', 'description': 'connective tissue will be used', 'interventionNames': ['Procedure: Leukocyte Platelet rich fibrin membrane']}], 'interventions': [{'name': 'Leukocyte Platelet rich fibrin membrane', 'type': 'PROCEDURE', 'otherNames': ['sub epithelial connective tissue'], 'description': 'the use of Leukocyte Platelet rich fibrin as grafting materials for treatment of recession', 'armGroupLabels': ['Leukocyte Platelet Rich Fibrin', 'connective tissue']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'ahmed abdel aziz, co professor', 'role': 'STUDY_CHAIR', 'affiliation': 'faculty of dentistry ain shams university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'teaching assistant', 'investigatorFullName': 'Zainab Hafez Abdel Rahman', 'investigatorAffiliation': 'Ain Shams University'}}}}