Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-02 @ 9:16 AM
Study NCT ID:
NCT02248103
Status:
COMPLETED
Last Update Posted:
2017-04-24
First Post:
2014-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Autogenous Periosteal Pedicle Graft and Collagen Membrane in Management of Periodontal Intrabony Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'noha.ghallab@dentistry.cu.edu.eg', 'phone': '+201005263365', 'title': 'Ass. Prof. Dr. Noha Ghallab', 'organization': 'Faculty of Oral and Dental Medicine Cairo University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Periosteal Pedicle Graft', 'description': 'autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.\n\nPeriosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bioresorbable Collagen Membrane', 'description': 'Equine Achilles tendon collagen barrier membrane\n\nBioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Attachment Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Periosteal Pedicle Graft', 'description': 'autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.\n\nPeriosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum'}, {'id': 'OG001', 'title': 'Bioresorbable Collagen Membrane', 'description': 'Equine Achilles tendon collagen barrier membrane\n\nBioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration'}], 'classes': [{'title': 'Baseline CAL', 'categories': [{'measurements': [{'value': '6.42', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '6.15', 'spread': '0.98', 'groupId': 'OG001'}]}]}, {'title': 'CAL after 6 months', 'categories': [{'measurements': [{'value': '3.52', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Estimation of clinical attachment level in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'defects'}, {'type': 'SECONDARY', 'title': 'Pocket Depth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Periosteal Pedicle Graft', 'description': 'autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.\n\nPeriosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum'}, {'id': 'OG001', 'title': 'Bioresorbable Collagen Membrane', 'description': 'Equine Achilles tendon collagen barrier membrane\n\nBioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration'}], 'classes': [{'title': 'Baseline PD', 'categories': [{'measurements': [{'value': '6.92', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '6.82', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'PD after 6 months', 'categories': [{'measurements': [{'value': '3.17', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '3.15', 'spread': '0.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Estimation of pocket depth in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Defect Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Periosteal Pedicle Graft', 'description': 'autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.\n\nPeriosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum'}, {'id': 'OG001', 'title': 'Bioresorbable Collagen Membrane', 'description': 'Equine Achilles tendon collagen barrier membrane\n\nBioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration'}], 'classes': [{'title': 'Baseline bone defect area', 'categories': [{'measurements': [{'value': '8.37', 'spread': '4.13', 'groupId': 'OG000'}, {'value': '9.25', 'spread': '3.23', 'groupId': 'OG001'}]}]}, {'title': 'Bone defect area after 6 months', 'categories': [{'measurements': [{'value': '4.42', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '2.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'linear measurements collected from a digital radiography program to estimate percentage of defect fill.', 'unitOfMeasure': '"mm^2"', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Periosteal Pedicle Graft', 'description': 'autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.\n\nPeriosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum'}, {'id': 'FG001', 'title': 'Bioresorbable Collagen Membrane', 'description': 'Equine Achilles tendon collagen barrier membrane\n\nBioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Periosteal Pedicle Graft', 'description': 'autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.\n\nPeriosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum'}, {'id': 'BG001', 'title': 'Bioresorbable Collagen Membrane', 'description': 'Equine Achilles tendon collagen barrier membrane\n\nBioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.81', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '37.81', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '37.81', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-21', 'studyFirstSubmitDate': '2014-09-20', 'resultsFirstSubmitDate': '2015-08-10', 'studyFirstSubmitQcDate': '2014-09-23', 'lastUpdatePostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-09-08', 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Attachment Level', 'timeFrame': 'Baseline and 6 months', 'description': 'Estimation of clinical attachment level in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration'}], 'secondaryOutcomes': [{'measure': 'Pocket Depth', 'timeFrame': 'Baseline and 6 months', 'description': 'Estimation of pocket depth in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration'}, {'measure': 'Bone Defect Area', 'timeFrame': 'Baseline and 6 months', 'description': 'linear measurements collected from a digital radiography program to estimate percentage of defect fill.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Periodontitis']}, 'referencesModule': {'references': [{'pmid': '22612365', 'type': 'RESULT', 'citation': 'Singhal R, Nandlal, Kumar A, Rastogi P. Role of space provision in regeneration of localized two-wall intrabony defects using periosteal pedicle graft as an autogenous guided tissue membrane. J Periodontol. 2013 Mar;84(3):316-24. doi: 10.1902/jop.2012.110734. Epub 2012 May 21.'}, {'pmid': '19055224', 'type': 'RESULT', 'citation': 'Gamal AY, Mailhot JM. A novel marginal periosteal pedicle graft as an autogenous guided tissue membrane for the treatment of intrabony periodontal defects. J Int Acad Periodontol. 2008 Oct;10(4):106-17.'}, {'pmid': '20583915', 'type': 'RESULT', 'citation': "Paolantonio M, Femminella B, Coppolino E, Sammartino G, D'Arcangelo C, Perfetti G, Perinetti G. Autogenous periosteal barrier membranes and bone grafts in the treatment of periodontal intrabony defects of single-rooted teeth: a 12-month reentry randomized controlled clinical trial. J Periodontol. 2010 Nov;81(11):1587-95. doi: 10.1902/jop.2010.100094. Epub 2010 Jun 28."}, {'pmid': '11288796', 'type': 'RESULT', 'citation': 'Bunyaratavej P, Wang HL. Collagen membranes: a review. J Periodontol. 2001 Feb;72(2):215-29. doi: 10.1902/jop.2001.72.2.215.'}, {'pmid': '23842107', 'type': 'RESULT', 'citation': 'Stoecklin-Wasmer C, Rutjes AW, da Costa BR, Salvi GE, Juni P, Sculean A. Absorbable collagen membranes for periodontal regeneration: a systematic review. J Dent Res. 2013 Sep;92(9):773-81. doi: 10.1177/0022034513496428. Epub 2013 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'A clinical and radiographic evaluation of autogenous periosteal pedicle graft in comparison with collagen membrane for management of periodontal intrabony defects.', 'detailedDescription': 'Twenty patients suffering from advanced chronic periodontitis were included in this randomized controlled clinical trial. Each subject contributed matched pairs of two- or three-walled intrabony defects. Each pair of periodontal defects were randomly assigned into the experimental group; periosteal pedicle graft guided tissue membrane or the positive control group; bioresorbable collagen guided tissue regeneration membrane. Clinical and radiographic parameters were recorded at baseline and at 6 months postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe chronic periodontitis patients with at least two sites with pocket depth ≥ 6 mm and clinical attachment level ≥ 5 mm, with radiographic evidence of bone loss 2- or 3-wall intrabony defect depth ranging from 3 to 6 mm as detected in periapical radiographs\n* The facial surface of teeth adjacent to the interproximal defect should be free of extensive recession and marginal bone loss, with at least a 4 to 5 mm band of keratinized gingiva to allow for periosteal manipulation\n\nExclusion Criteria:\n\n* Pregnant women\n* Subjects had \\<22 permanent teeth\n* Having any given systemic disease\n* Taking any type of medication and/or antibiotic therapy during the 3 months before the study\n* Received periodontal treatment within the past 12 months\n* Current or former smokers'}, 'identificationModule': {'nctId': 'NCT02248103', 'briefTitle': 'Comparison of Autogenous Periosteal Pedicle Graft and Collagen Membrane in Management of Periodontal Intrabony Defects', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparison of Autogenous Periosteal Pedicle Graft and Collagen Membrane in Management of Periodontal Intrabony Defects: A Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'MPP graft_GTR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'periosteal pedicle graft', 'description': 'autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.', 'interventionNames': ['Procedure: Periosteal pedicle graft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bioresorbable collagen membrane', 'description': 'Equine Achilles tendon collagen barrier membrane', 'interventionNames': ['Biological: Bioresorbable collagen membrane']}], 'interventions': [{'name': 'Periosteal pedicle graft', 'type': 'PROCEDURE', 'description': 'Autogenous pedicle graft harvested from the periosteum', 'armGroupLabels': ['periosteal pedicle graft']}, {'name': 'Bioresorbable collagen membrane', 'type': 'BIOLOGICAL', 'description': 'Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration', 'armGroupLabels': ['Bioresorbable collagen membrane']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Noha Ghallab, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of periodontology faulty of oral and dental medicine Cairo Unv.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of periodontology, faculty of oral and dental medicine', 'investigatorFullName': 'Noha Ayman Ghallab', 'investigatorAffiliation': 'Cairo University'}}}}