Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT02221557
Status:
COMPLETED
Last Update Posted:
2017-08-10
First Post:
2014-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Case Series of New Alloplastic Bone Graft Material
Sponsor:
Organization:
Raw JSON
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Upon sponsor's written request, publication will be delayed up to 60 days to enable sponsor to secure adequate intellectual property protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'New Alloplastic Bone Graft Material', 'description': 'easy-graft (beta-Tricalcium Phosphate)', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change in Radiographic Measurement of Alveolar Ridge Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'New Alloplastic Bone Graft Material', 'description': 'easy-graft (beta-Tricalcium Phosphate)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '6.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 6 months', 'description': 'Radiographic measurement was taken at most-middle portion of the grafted site, perpendicular to the line drawn from reference point (e.g. adjacent tooth/teeth Cement-Enamel Junction (CEJ) or margin of the restoration).', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'New Alloplastic Bone Graft Material', 'description': 'easy-graft (beta-Tricalcium Phosphate)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'New Alloplastic Bone Graft Material', 'description': 'easy-graft (beta-Tricalcium Phosphate)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Widest ridge width', 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '2.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Deepest vertical depth', 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'spread': '2.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Widest open', 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '2.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-08', 'studyFirstSubmitDate': '2014-08-14', 'resultsFirstSubmitDate': '2017-07-10', 'studyFirstSubmitQcDate': '2014-08-18', 'lastUpdatePostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-08', 'studyFirstPostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Radiographic Measurement of Alveolar Ridge Height', 'timeFrame': 'Change from baseline to 6 months', 'description': 'Radiographic measurement was taken at most-middle portion of the grafted site, perpendicular to the line drawn from reference point (e.g. adjacent tooth/teeth Cement-Enamel Junction (CEJ) or margin of the restoration).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Periodontology', 'Oral Surgery']}, 'descriptionModule': {'briefSummary': 'A case series to compare the handling and effectiveness of two different treatment approaches using a new alloplastic bone graft material in ridge preservation compared to allograft existing historical data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have read, understood and signed a consent form.\n* 18-75 years of age\n* Diagnosis with a need of extraction of single tooth (with intact extraction socket at the time of extraction) with adjacent teeth present.\n\nExclusion Criteria:\n\n* Active caries or endodontic lesions in adjacent teeth\n* Any systemic disease or condition that would compromise the normal healing. (e.g., uncontrolled diabetes)\n* Taking any medication known for gingival hyperplasia for past 3 months.\n* Any systemic contraindications to surgery\n* Subject smokes \\> 10 cigarettes per day.'}, 'identificationModule': {'nctId': 'NCT02221557', 'briefTitle': 'Case Series of New Alloplastic Bone Graft Material', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sunstar Americas'}, 'officialTitle': 'Clinical and Histomorphometric Evaluation of Beta-tricalcium Phosphate/Polylactide Bone Substitute for Socket Preservation', 'orgStudyIdInfo': {'id': '2014-7-1-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'New alloplastic bone graft material', 'interventionNames': ['Device: easy-graft (beta-Tricalcium Phosphate)']}], 'interventions': [{'name': 'easy-graft (beta-Tricalcium Phosphate)', 'type': 'DEVICE', 'armGroupLabels': ['New alloplastic bone graft material']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland School of Dentistry', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunstar Americas', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}