Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-31 @ 2:25 AM
Study NCT ID:
NCT07042204
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-27
First Post:
2025-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of E-prf Alone and in Combination With Bioactive Glass Nanoparticles in Grade II Furcation Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017823', 'term': 'Furcation Defects'}], 'ancestors': [{'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': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-08-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-06-26', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome will be the amount of bone fill vertically and horizontally obtained in the treatment of grade II furcation defects calculated from CBCT data in millimeters', 'timeFrame': '6 months follow up'}], 'secondaryOutcomes': [{'measure': 'the secondary outcomes include improvements (decrease)of probing depth in millimetres', 'timeFrame': '3 and 6 months follow up', 'description': 'Using UNC-15 periodontal probe to measure the probing depth from the base of the pocket to the free gingival margin. All measurements will be rounded off to the nearest millimetre.'}, {'measure': 'the secondary outcomes include improvements (decrease)of clinical attachment level loss in millimetres', 'timeFrame': '3 and 6 months follow up', 'description': 'using a UNC-15 periodontal probe to measure clinical attachment level loss from the cemento-enamel junction (CEJ) to the pocket depth. All measurements will be rounded off to the nearest millimetre'}, {'measure': 'the secondary outcomes include improvements (decrease) of gingival recession measured in millimetres', 'timeFrame': '3 and 6 months follow up', 'description': 'Using a UNC-15 periodontal probe to measure gingival recession from cemento-enamel junction (CEJ) to the free gingival margin. All measurements will be rounded off to the nearest millimetre'}, {'measure': 'the secondary outcomes include improvements (decrease) of gingival bleeding index', 'timeFrame': '3 and 6 months follow up', 'description': "It's performed through gentle probing of the orifice of the gingival crevice using a UNC-15 periodontal probe. If bleeding occurs within 10 seconds a positive finding is recorded, and the number of positive sites is recorded and then expressed as a percentage of the number of the sites examined."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Furcation Defects']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate and compare the effectiveness of extended platelet-rich fibrin (ePRF) alone and in combination with bioactive glass nanoparticles in the treatment of grade II furcation defects clinically and radiographically.', 'detailedDescription': 'A total of 30 grade II furcation defects will be randomly divided into three groups as follows:\n\nGroup I: 10 grade II furcation defects will be treated by extended platelet-rich fibrin (ePRF) alone.\n\nGroup II: 10 grade II furcation defects will be treated by bioactive glass nanoparticles mixed with extended platelet-rich fibrin (BGn+ePRF).\n\nGroup III: 10 grade II furcation defects will be treated by bioactive glass nanoparticles with collagen membrane.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Presence of Glickman's grade II furcation defects in molars probing depth (PD) ≥5 mm horizontal PD ≥3 mm.\n* The patients are in good systemic health and had not undergone any periodontal surgery in the areas to be treated within the prior 12 months.\n\nExclusion Criteria:\n\n* Smokers and tobacco chewers.\n* Patients that take any medications within the past 6 months that could alter their periodontal status.\n* pregnant or lactating females.\n* Patients with known allergy to materials or drugs that will be used or prescribed in this study."}, 'identificationModule': {'nctId': 'NCT07042204', 'briefTitle': 'Effectiveness of E-prf Alone and in Combination With Bioactive Glass Nanoparticles in Grade II Furcation Defects', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Effectiveness of Extended Platelet-Rich Fibrin (ePRF) Alone and in Combination With Bioactive Glass Nanoparticles in the Treatment of Grade II Furcation Defects', 'orgStudyIdInfo': {'id': 'A03011023OM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': '10 grade II furcation defects will be treated by extended platelet-rich fibrin (ePRF) alone.', 'interventionNames': ['Procedure: Group I (extended platelet-rich fibrin)']}, {'type': 'EXPERIMENTAL', 'label': 'Group II', 'description': '10 grade II furcation defects will be treated by bioactive glass nanoparticles mixed with extended platelet-rich fibrin (BGn+ePRF).', 'interventionNames': ['Procedure: Group II (bioactive glass nanoparticles mixed with extended platelet-rich fibrin)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III', 'description': '10 grade II furcation defects will be treated by bioactive glass nanoparticles with collagen membrane.', 'interventionNames': ['Procedure: Group III (bioactive glass nanoparticles and covered by a collagen membrane)']}], 'interventions': [{'name': 'Group I (extended platelet-rich fibrin)', 'type': 'PROCEDURE', 'description': 'mucoperiosteal flap will be raised through sulcular incisions Debridement of granulation tissue from the osseous defect and furcation will be filled with (ePRF) at the first group', 'armGroupLabels': ['Group I']}, {'name': 'Group II (bioactive glass nanoparticles mixed with extended platelet-rich fibrin)', 'type': 'PROCEDURE', 'description': 'bioactive glass nanoparticles mixed with extended platelet-rich fibrin (BGn+ePRF)', 'armGroupLabels': ['Group II']}, {'name': 'Group III (bioactive glass nanoparticles and covered by a collagen membrane)', 'type': 'PROCEDURE', 'description': 'bioactive glass nanoparticles and covered by a collagen membrane', 'armGroupLabels': ['Group III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': "Merna N Elnahas, Master's degree", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura Unniversity'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merna Nasser Mohamed Mostafa Ibrahim Elnahas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'BDS, Clinical demonstrator, Oral Medicine, Periodontology, Diagnosis and Oral Radiology Department', 'investigatorFullName': 'Merna Nasser Mohamed Mostafa Ibrahim Elnahas', 'investigatorAffiliation': 'Mansoura University'}}}}