Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2026-01-09 @ 7:40 AM
Study NCT ID:
NCT02609061
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2015-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet Rich Fibrin+1% Alendronate 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': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-17', 'studyFirstSubmitDate': '2015-11-15', 'studyFirstSubmitQcDate': '2015-11-17', 'lastUpdatePostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic bone fill', 'timeFrame': 'baseline to 9 months', 'description': 'assessed in percentage'}], 'secondaryOutcomes': [{'measure': 'probing depth', 'timeFrame': 'baseline to 9 months', 'description': 'measured in mm'}, {'measure': 'Relative vertical attachment level', 'timeFrame': 'baseline to 9 months', 'description': 'measured in mm'}, {'measure': 'Relative horizontal attachment level', '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'}]}, 'conditionsModule': {'conditions': ['Furcation Defects']}, 'referencesModule': {'references': [{'pmid': '27712462', 'type': 'DERIVED', 'citation': 'Kanoriya D, Pradeep AR, Garg V, Singhal S. Mandibular Degree II Furcation Defects Treatment With Platelet-Rich Fibrin and 1% Alendronate Gel Combination: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):250-258. doi: 10.1902/jop.2016.160269. Epub 2016 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the treatment of mandibular degree II furcation defects when compared with PRF and open flap debridement (OFD) alone.', 'detailedDescription': 'Background: Various regenerative materials have been introduced and tested in the treatment of furcation defects. Platelet-rich fibrin (PRF) is a reservoir of growth factors and cytokines which are the key factors for regeneration of bone and maturation of the soft tissue. Alendronate (ALN), a potent member of bisphosphonate group is known to promote tissue regeneration by inhibiting osteoclastic bone resorption and promoting osteoblastogenesis. The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the treatment of mandibular degree II furcation defects when compared with PRF and open flap debridement (OFD) alone.\n\nMethods: Seventy two mandibular furcation defects were treated with either OFD alone (Group 1), OFD with PRF (Group 2), and OFD with PRF+1% ALN (Group 3). Clinical parameters; site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), relative vertical attachment level (RVAL) and relative horizontal attachment level (RHAL), intrabony defect depth (IBD) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic defect fill was evaluated at baseline and 9 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of buccal Class 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* 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 (\\<200,000/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\n* Aggressive periodontitis'}, 'identificationModule': {'nctId': 'NCT02609061', 'briefTitle': 'Platelet Rich Fibrin+1% Alendronate 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% Alendronate Gel in Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'GDCRI/ACM/PG/PhD/2/2013-2014T'}}, '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% Alendronate for treating furcation defect', 'interventionNames': ['Procedure: OFD with Platelet rich fibrin (PRF)+1% Alendronate (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% Alendronate (Drug) in gel form', 'type': 'PROCEDURE', 'description': 'Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate 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'}}}}