Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-23 @ 5:33 AM
Study NCT ID:
NCT02515058
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2015-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016301', 'term': 'Alveolar Bone Loss'}], 'ancestors': [{'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mealey@uthscsa.edu', 'phone': '210-567-3567', 'title': 'Dr. Brian Mealey', 'organization': 'UT Health Science Center at San Antonio'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '20 months', 'eventGroups': [{'id': 'EG000', 'title': 'Non-Freeze-Dried Bone Allograft (PUROS)', 'description': 'Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)\n\nPUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Freeze-Dried Bone Allograft (FDBA)', 'description': 'Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)\n\nFDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Head trauma', 'notes': 'Patient fell at home, head trauma, went into ER, hospitalized for 2 days, MRI, CT scan, obtained medical clearance, follow up in with MD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '% Vital Bone Formation (Histological)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Freeze-Dried Bone Allograft (PUROS)', 'description': 'Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)\n\nPUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction'}, {'id': 'OG001', 'title': 'Freeze-Dried Bone Allograft (FDBA)', 'description': 'Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)\n\nFDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction'}], 'classes': [{'categories': [{'measurements': [{'value': '27.19', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '24.08', 'spread': '12.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after ridge preservation', 'description': 'histologic determination of % of vital bone formation', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '% Residual Graft Material (Histological)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Freeze-Dried Bone Allograft (PUROS)', 'description': 'Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)\n\nPUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction'}, {'id': 'OG001', 'title': 'Freeze-Dried Bone Allograft (FDBA)', 'description': 'Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)\n\nFDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction'}], 'classes': [{'categories': [{'measurements': [{'value': '23.38', 'spread': '13.45', 'groupId': 'OG000'}, {'value': '22.96', 'spread': '21.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after ridge preservation', 'description': 'histologic determination of % of residual bone graft material', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-Freeze-Dried Bone Allograft (PUROS)', 'description': 'Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)\n\nPUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction'}, {'id': 'FG001', 'title': 'Freeze-Dried Bone Allograft (FDBA)', 'description': 'Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)\n\nFDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'After enrollment, one subject was withdrawn as a screen failure. This left a total of 43 subjects enrolled to take part in the study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Non-Freeze-Dried Bone Allograft (PUROS)', 'description': 'Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)\n\nPUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction'}, {'id': 'BG001', 'title': 'Freeze-Dried Bone Allograft (FDBA)', 'description': 'Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)\n\nFDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction'}, {'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': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-30', 'size': 1085658, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-10-25T22:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-18', 'studyFirstSubmitDate': '2015-07-31', 'resultsFirstSubmitDate': '2017-09-27', 'studyFirstSubmitQcDate': '2015-08-03', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-26', 'studyFirstPostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% Vital Bone Formation (Histological)', 'timeFrame': '3 months after ridge preservation', 'description': 'histologic determination of % of vital bone formation'}], 'secondaryOutcomes': [{'measure': '% Residual Graft Material (Histological)', 'timeFrame': '3 months after ridge preservation', 'description': 'histologic determination of % of residual bone graft material'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alveolar Bone Loss']}, 'referencesModule': {'references': [{'pmid': '30161278', 'type': 'DERIVED', 'citation': 'Corning PJ, Mealey BL. Ridge preservation following tooth extraction using mineralized freeze-dried bone allograft compared to mineralized solvent-dehydrated bone allograft: A randomized controlled clinical trial. J Periodontol. 2019 Feb;90(2):126-133. doi: 10.1002/JPER.18-0199. Epub 2018 Sep 19.'}]}, 'descriptionModule': {'briefSummary': 'The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bone allograft that has been prepared by either freeze-drying or via a non-freeze-dried solvent process.This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called FDBA). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).\n\nEach subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a resorbable collagen membrane. Following 3 months of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.', 'detailedDescription': 'The study is designed to examine histologic wound healing following ridge preservation using cancellous bone allograft that has been prepared either by freeze-drying (FDBA) or by a solvent-based processing method (PUROS). This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called FDBA). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).\n\nEach subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a resorbable collagen membrane. Following 3 months of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:Patients will be included in this study if they qualify the following inclusion criteria:\n\n* Live within 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio\n* Are able to attend a minimum of 6 visits over a 4-5 month period, as required by the study protocol\n* A single rooted tooth that has been identified as requiring extraction\n* Desire a dental implant to replace the missing tooth\n* Have adequate restorative space for a dental implant-retained restoration\n* Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.\n* Have a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50% of the total depth of the socket.\n* Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential.\n* Are nonsmokers or former smokers. Current smokers may only be included if they smoke \\<10 cigarettes per day\n\nExclusion Criteria:\n\n* Patients who live more than 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio\n* Patients who do not meet all the inclusion criteria or who will not cooperate with the required follow-up schedule.\n* Patients will are mentally incompetent, prisoners, or pregnant.\n* Pregnant women or women intending to become pregnant during the study period.\n* Smokers who smoke \\>10 cigarettes per day\n* Clinical and/or radiographic determinations which will preclude inclusion in this study are: Active infection other than periodontitis; Inadequate bone dimensions or restorative space for a dental implant; Presence of a disease entity, condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, autoimmune diseases, history of bisphosphonate use or long-term steroid therapy; Positive medical history of endocarditis following oral or dental surgery.\n* Sensitivity or allergy to Bacitracin, Gentamicin, Polymyxin B Sulfate, alcohol and/or surfactants'}, 'identificationModule': {'nctId': 'NCT02515058', 'briefTitle': 'Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Ridge Preservation Following Tooth Extraction Using Mineralized Freeze-Dried Bone Allograft Compared to PUROS Mineralized Bone Allograft', 'orgStudyIdInfo': {'id': '15-0552H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PUROS (Non-Freeze-Dried bone allograft)', 'description': 'Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)', 'interventionNames': ['Device: PUROS (Ridge Preservation bone grafting surgery)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FDBA (Freeze-Dried bone allograft)', 'description': 'Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)', 'interventionNames': ['Device: FDBA (Ridge Preservation bone grafting surgery)']}], 'interventions': [{'name': 'PUROS (Ridge Preservation bone grafting surgery)', 'type': 'DEVICE', 'description': 'Ridge preservation bone grafting after tooth extraction', 'armGroupLabels': ['PUROS (Non-Freeze-Dried bone allograft)']}, {'name': 'FDBA (Ridge Preservation bone grafting surgery)', 'type': 'DEVICE', 'description': 'Ridge preservation bone grafting after tooth extraction', 'armGroupLabels': ['FDBA (Freeze-Dried bone allograft)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Health Science Center at San Antonio, School of Dentistry', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Brian L. Mealey, DDS, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Health Science Center at San Antonio, School of Dentistry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Graduate Program Director, Periodontics', 'investigatorFullName': 'Brian L Mealey', 'investigatorAffiliation': 'The University of Texas Health Science Center at San Antonio'}}}}