Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT04338516
Status:
COMPLETED
Last Update Posted:
2025-12-15
First Post:
2020-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Ridge Preservation Using a Ossix™ Bone vs Bio-Oss® Collagen
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PalaiologouA@uthscsa.edu', 'phone': '210-450 8736', 'title': 'Angela Palaiologou-Gallis , DDS., MS', 'organization': 'UT Health San Antonio (UTHSA), San Antonio, Texas'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '16 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'BioOss Collagen', 'description': 'no adverse events were observed', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'OSSIX™ Bone', 'description': 'no subject suffered any adverse event due to the materials tested', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Vital Bone Formation,', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bio-Oss® Collagen,', 'description': 'subjects treated with Bio-Oss® Collagen, (Geistlich, Inc.)\n\nBio-Oss® Collagen: 90% bovine derived xenograft granules and 10% porcine collagen'}, {'id': 'OG001', 'title': 'Ossix™ Bone', 'description': 'subjects treated with Ossix™ Bone (Datum Dental Ltd)\n\nOssix™ Bone: a resorbable sponge-like matrix of 80% hydroxyapatite and 20% sugar cross-linked porcine collagen'}], 'classes': [{'categories': [{'measurements': [{'value': '26.8', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '39.3', 'spread': '17.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'shows the amount of new bone formed after the procedure', 'unitOfMeasure': 'percentage of vital bone', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Residual Graft Material', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bio-Oss® Collagen,', 'description': 'subjects treated with Bio-Oss® Collagen, (Geistlich, Inc.)\n\nBio-Oss® Collagen: 90% bovine derived xenograft granules and 10% porcine collagen'}, {'id': 'OG001', 'title': 'Ossix™ Bone', 'description': 'subjects treated with Ossix™ Bone (Datum Dental Ltd)\n\nOssix™ Bone: a resorbable sponge-like matrix of 80% hydroxyapatite and 20% sugar cross-linked porcine collagen'}], 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'shows how much of the graft material remained intact', 'unitOfMeasure': 'percentage of residual graft', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Fibrous Tissue and Marrow Space', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bio-Oss® Collagen,', 'description': 'subjects treated with Bio-Oss® Collagen, (Geistlich, Inc.)\n\nBio-Oss® Collagen: 90% bovine derived xenograft granules and 10% porcine collagen'}, {'id': 'OG001', 'title': 'Ossix™ Bone', 'description': 'subjects treated with Ossix™ Bone (Datum Dental Ltd)\n\nOssix™ Bone: a resorbable sponge-like matrix of 80% hydroxyapatite and 20% sugar cross-linked porcine collagen'}], 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '60.7', 'spread': '17.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'amount of tissue that is neither native bone or graft material', 'unitOfMeasure': 'percentage of marrow', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bio-Oss® Collagen,', 'description': 'subjects treated with Bio-Oss® Collagen, (Geistlich, Inc.)\n\nBio-Oss® Collagen: 90% bovine derived xenograft granules and 10% porcine collagen'}, {'id': 'FG001', 'title': 'Ossix™ Bone', 'description': 'subjects treated with Ossix™ Bone (Datum Dental Ltd)\n\nOssix™ Bone: a resorbable sponge-like matrix of 80% hydroxyapatite and 20% sugar cross-linked porcine collagen'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BioOss Collagen', 'description': 'no adverse events were observed'}, {'id': 'BG001', 'title': 'Ossix™ Bone', 'description': 'no adverse events were observed'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], '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': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', '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': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '80'}, {'value': '55', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '80'}, {'value': '55', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '80'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'YEARS', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-24', 'size': 400441, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-11-03T03:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2020-04-05', 'resultsFirstSubmitDate': '2025-11-03', 'studyFirstSubmitQcDate': '2020-04-05', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-11', 'studyFirstPostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Vital Bone Formation,', 'timeFrame': '16 weeks', 'description': 'shows the amount of new bone formed after the procedure'}, {'measure': 'Percent Residual Graft Material', 'timeFrame': '16 weeks', 'description': 'shows how much of the graft material remained intact'}, {'measure': 'Percent Fibrous Tissue and Marrow Space', 'timeFrame': '16 weeks', 'description': 'amount of tissue that is neither native bone or graft material'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['TEETH EXTRACTION']}, 'referencesModule': {'references': [{'pmid': '35661358', 'type': 'DERIVED', 'citation': 'Casarez-Quintana A, Mealey BL, Kotsakis G, Palaiologou A. Comparing the histological assessment following ridge preservation using a composite bovine-derived xenograft versus an alloplast hydroxyapatite-sugar cross-linked collagen matrix. J Periodontol. 2022 Nov;93(11):1691-1700. doi: 10.1002/JPER.22-0149. Epub 2022 Jul 1.'}]}, 'descriptionModule': {'briefSummary': 'This randomized, parallel design, controlled study will assess the histologic healing of this Ossix™ Bone in humans and compare it to a Bio-Oss® Collagen that is well researched.\n\nSubjects will be enrolled into 2 groups. Each subject will provide a single non-molar tooth site for study treatment. The tooth will be extracted, the extraction socket will be filled with one of the study bone grafts. No wound dressing or membrane will be used to cover the bone graft material as both materials can be used alone. An core biopsy will be collected after 16 weeks of healing during the implant placement.\n\nThe study will evaluate if there is a difference in histologic wound healing following tooth extraction and ridge preservation between groups treated with Bio-Oss® Collagen compared to Ossix™ Bone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* One tooth, excluding molars, that has been identified by dental faculty as requiring a single tooth extraction\n\n * A dental implant is indicated and treatment planned 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 be included if they smoke \\<10 cigarettes per day\n\nExclusion Criteria:\n\n* Will not cooperate with the follow-up schedule. Patients will not be entered who are mentally incompetent, prisoners, or pregnant.\n\n * Pregnant women or women intending to become pregnant during the study period (as confirmed verbally; an over the counter pregnancy test will be provided if pregnancy status is unknown or suspected).\n * Patients who become pregnant during the study will be withdrawn and standard care will be delivered.\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.'}, 'identificationModule': {'nctId': 'NCT04338516', 'briefTitle': 'Ridge Preservation Using a Ossix™ Bone vs Bio-Oss® Collagen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Datum Dental LTD'}, 'officialTitle': 'Histological Evaluation of Healing Following Ridge Preservation Using a Composite Bovine Derived Xenograft or a Hydroxyapatite-Collagen Matrix', 'orgStudyIdInfo': {'id': 'HSC20190455H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bio-Oss® Collagen,', 'description': 'subjects treated with Bio-Oss® Collagen, (Geistlich, Inc.)', 'interventionNames': ['Device: Bio-Oss® Collagen']}, {'type': 'EXPERIMENTAL', 'label': 'Ossix™ Bone', 'description': 'subjects treated with Ossix™ Bone (Datum Dental Ltd)', 'interventionNames': ['Device: Ossix™ Bone']}], 'interventions': [{'name': 'Ossix™ Bone', 'type': 'DEVICE', 'description': 'a resorbable sponge-like matrix of 80% hydroxyapatite and 20% sugar cross-linked porcine collagen', 'armGroupLabels': ['Ossix™ Bone']}, {'name': 'Bio-Oss® Collagen', 'type': 'DEVICE', 'description': '90% bovine derived xenograft granules and 10% porcine collagen', 'armGroupLabels': ['Bio-Oss® Collagen,']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229-3900', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Health San Antonio (UTHSA)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Datum Dental LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}