Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-02-20 @ 4:44 PM
Study NCT ID:
NCT02949557
Status:
COMPLETED
Last Update Posted:
2016-10-31
First Post:
2016-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DFDBA and Xenograft (Cerabone)TM With Decortication in Intrabony Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-10-06', 'releaseDate': '2017-05-16'}, {'resetDate': '2020-09-09', 'releaseDate': '2020-08-21'}, {'resetDate': '2021-01-21', 'releaseDate': '2021-01-01'}, {'resetDate': '2021-02-10', 'releaseDate': '2021-01-22'}, {'resetDate': '2021-03-05', 'releaseDate': '2021-02-15'}, {'resetDate': '2021-03-30', 'releaseDate': '2021-03-05'}], 'estimatedResultsFirstSubmitDate': '2017-05-16'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D002541', 'term': 'Cerebral Decortication'}, {'id': 'D016025', 'term': 'Bone Transplantation'}], 'ancestors': [{'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2016-10-27', 'studyFirstSubmitQcDate': '2016-10-27', 'lastUpdatePostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical attachment level', 'timeFrame': '9 months', 'description': 'clinical attachment level measured in mm from cementoenamel junction to the base of the pocket'}, {'measure': 'Bone fill', 'timeFrame': '9 months', 'description': 'Bone fill measured in mm in radiographs from alveolar crest to base of the pocket'}, {'measure': 'Pocket probing depth', 'timeFrame': '9 months', 'description': 'pocket probing depth level measured in mm from gingival margin to base of the pocket'}], 'secondaryOutcomes': [{'measure': 'Plaque Index (PI)', 'timeFrame': '9 month', 'description': 'Plaque index is measured for periodontal health'}, {'measure': 'Periodontal disease index', 'timeFrame': '9 months', 'description': 'Periodontal disease index is measured for periodontal health'}, {'measure': 'Gingival Bleeding Index', 'timeFrame': '9 months', 'description': 'Gingival bleeding index is measured for periodontal health'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Periodontal Intrabony Defects']}, 'descriptionModule': {'briefSummary': 'DFDBA is an allograft that possesses osteoconductive and osteoinductive properties. It has the potential for osteoinduction due to increased expression of bone morphogenetic protein (BMP).Cerabone™ has shown maximum resemblance to human bone with the potential to reconstruct bone defects. Decortication is performed as a part of guided bone regeneration (GBR) procedure as it enhances the healing process.Therefore a combination of decortication and bone graft when applied in periodontal intrabony defect would enhance the regeneration of periodontium.', 'detailedDescription': 'There have been great strides in the management of periodontal intrabony defects, especially with the use of bone graft materials. It is necessary to choose the most appropriate material and procedure in order to obtain the desired regeneration. Among the bone grafts, Demineralised freezed dried bone allograft (DFDBA) and xenografts have shown good results in the management of intrabony defects. Recently, a novel bovine xenograft i.e., Cerabone™ has shown maximum resemblance to human bone with the potential to reconstruct bone defects. Decortication or intramarrow penetration of the bone has shown favourable results in guided bone regeneration procedures. So the goal of the present study was to check the efficacy of decortication with decalcified freeze dried bone allograft (DFDBA) and Cerabone™ bone grafts and to compare the response between the bonegrafts placed following decortication using RVG and CBCT, in intrabony defect.\n\nThe combination of decortication with bone grafts i.e., DFDBA and (Cerabone)TM can be an added advantage in the treatment of intrabony defects. To the best of the investigators knowledge no clinical trial reports this combination therapy in scientific literature. There is need for further research in this area.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age group 25-45 years\n* Moderate periodontitis with pocket probing depth more than 5 mm\n* Bilaterally similiar intrabony defects\n* systemically healthy patients\n* Good compliance\n\nExclusion Criteria:\n\n* medically compromised\n* Pregnant and lactating women\n* Smoking\n* teeth with mobility and furcation involvement'}, 'identificationModule': {'nctId': 'NCT02949557', 'briefTitle': 'DFDBA and Xenograft (Cerabone)TM With Decortication in Intrabony Defects', 'organization': {'class': 'OTHER', 'fullName': 'Krishnadevaraya College of Dental Sciences & Hospital'}, 'officialTitle': 'A Comparative Clinical and Radiographic Evaluation of Demineralized Freeze Dried Bone Allograft (DFDBA) and Xenograft (Cerabone)TM With Decortication in the Treatment of Periodontal Intraosseous Defects', 'orgStudyIdInfo': {'id': '02_D012_54500'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Decortication +DFDBA', 'description': 'After phase 1 therapy patients were assigned for decortication+ DFDBA group. Mucoperiosteal flaps were reflected. After open flap debridement, decortication was performed and DFDBA graft was placed in the treatment of intrabony defects.', 'interventionNames': ['Procedure: Decortication + bone grafts']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Decortication+ Xenograft (Cerabone)TM', 'description': 'After phase 1 therapy patients were assigned for decortication+ xenograft (Cerabone)TM group. Mucoperiosteal flaps were reflected. After open flap debridement, decortication was performed and DFDBA graft was placed in the treatment of intrabony defects.', 'interventionNames': ['Procedure: Decortication + bone grafts']}], 'interventions': [{'name': 'Decortication + bone grafts', 'type': 'PROCEDURE', 'armGroupLabels': ['Decortication +DFDBA', 'Decortication+ Xenograft (Cerabone)TM']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Krishnadevaraya College of Dental Sciences & Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-05-16', 'type': 'RELEASE'}, {'date': '2017-10-06', 'type': 'RESET'}, {'date': '2020-08-21', 'type': 'RELEASE'}, {'date': '2020-09-09', 'type': 'RESET'}, {'date': '2021-01-01', 'type': 'RELEASE'}, {'date': '2021-01-21', 'type': 'RESET'}, {'date': '2021-01-22', 'type': 'RELEASE'}, {'date': '2021-02-10', 'type': 'RESET'}, {'date': '2021-02-15', 'type': 'RELEASE'}, {'date': '2021-03-05', 'type': 'RESET'}, {'date': '2021-03-05', 'type': 'RELEASE'}, {'date': '2021-03-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Krishnadevaraya College of Dental Sciences & Hospital'}}}}