Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-20 @ 4:18 PM
Study NCT ID:
NCT02612792
Status:
COMPLETED
Last Update Posted:
2015-11-24
First Post:
2015-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet Rich Fibrin+1.2% Atorvastatin in Treatment of Mandibular Degree 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-23', 'studyFirstSubmitDate': '2015-11-20', 'studyFirstSubmitQcDate': '2015-11-23', 'lastUpdatePostDateStruct': {'date': '2015-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '. Radiographic bone fill assessed in percentage', 'timeFrame': 'baseline to 9 months', 'description': 'assessed in percentage'}], 'secondaryOutcomes': [{'measure': 'probing depth measured in mm', 'timeFrame': 'baseline to 9 months', 'description': 'measured in mm'}, {'measure': 'Relative vertical attachment level measured in mm', 'timeFrame': 'baseline to 9 months', 'description': 'measured in mm'}, {'measure': 'Relative horizontal attachment level measured in mm', 'timeFrame': 'baseline to 9 months', 'description': 'measured in mm'}, {'measure': 'modified sulcus bleeding index', 'timeFrame': 'baseline to 9 months', 'description': '0-3 scale'}, {'measure': 'plaque index', 'timeFrame': 'baseline to 9 months', 'description': '0-3 scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Furcation Defects']}, 'descriptionModule': {'briefSummary': 'The present study was designed to explore the effectiveness of PRF combined with 1.2% ATV gel in treatment of mandibular degree II furcation defects in comparison to PRF and open flap debridement (OFD) alone.', 'detailedDescription': 'Background: A variety of regenerative materials have been tried since many years for the treatment of furcation defects. Platelet-rich fibrin (PRF), a pool reservoir of platelet concentrate with growth factors and Atorvastatin (ATV), a potent member of statin group are known to promote periodontal tissue regeneration. The aim of the present study is to explore the effectiveness of PRF combined with 1.2% ATV gel in treatment of mandibular degree II furcation defects in comparison to PRF and open flap debridement (OFD) alone.\n\nMethods: Eighty two mandibular furcation defects were treated with either OFD alone (Group 1), OFD with PRF (Group 2), and OFD with PRF+1.2% ATV gel (Group 3).Clinical parameters like probing depth (PD), relative vertical clinical attachment level (RVCAL), relative horizontal clinical attachment level (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index (PI) were recorded at baseline and 9 months post-operatively. The radiological assessment of bone defect fill was done at baseline and 9 months, using computer-aided software.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Buccal degree II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD) ≥ 5mm and horizontal ≥ PD 3mm after phase I therapy i.e, scaling and root planing (SRP);\n* No history of antibiotic or periodontal therapy in the preceding 6 months.\n\nExclusion Criteria:\n\n* Aggressive periodontitis patients\n* Systemic conditions known to affect the periodontal status;\n* Medications known to affect the outcomes of periodontal therapy;\n* Hematological disorders and insufficient platelet count (\\<100,000/mm3);\n* Pregnancy/lactation;\n* Smoking and tobacco use in any form\n* Immunocompromised individuals;\n* Those having unacceptable oral hygiene (plaque index \\[PI\\] \\>1.5).\n* Teeth with furcation involvement, non-vital teeth, and carious teeth indicated for restorations and mobility of at least grade II were also excluded.'}, 'identificationModule': {'nctId': 'NCT02612792', 'briefTitle': 'Platelet Rich Fibrin+1.2% Atorvastatin in Treatment of Mandibular Degree II Furcation Defects', 'organization': {'class': 'OTHER', 'fullName': 'Government Dental College and Research Institute, Bangalore'}, 'officialTitle': 'Platelet Rich Fibrin Combined With 1.2% Atorvastatin Gel in Treatment of Mandibular Degree II Furcation Defects: a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'GDCRI/ACM/PG/PhD/2/2013-2014U'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect', 'interventionNames': ['Procedure: Open flap debridement (OFD)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect', 'interventionNames': ['Procedure: OFD with Platelet rich fibrin (PRF)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin for treating furcation defect', 'interventionNames': ['Procedure: OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel form']}], 'interventions': [{'name': 'Open flap debridement (OFD)', 'type': 'PROCEDURE', 'description': 'Open flap debridement (OFD) alone', 'armGroupLabels': ['Group 1']}, {'name': 'OFD with Platelet rich fibrin (PRF)', 'type': 'PROCEDURE', 'description': 'Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement', 'armGroupLabels': ['Group 2']}, {'name': 'OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel form', 'type': 'PROCEDURE', 'description': 'Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement', 'armGroupLabels': ['Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560002', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Government Dental College and Research Institute', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Government Dental College and Research Institute, Bangalore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Head, Dept of Periodontology', 'investigatorFullName': 'Dr. A R Pradeep', 'investigatorAffiliation': 'Government Dental College and Research Institute, Bangalore'}}}}