Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT00881959
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2009-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'haibo.wen@zimmer.com', 'phone': '760 929 4312', 'title': 'Hai Bo Wen', 'organization': 'Zimmer Dental'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: Puros Dermis', 'description': 'Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.', 'otherNumAtRisk': 38, 'otherNumAffected': 2, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2: Alloderm', 'description': 'Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Infection, Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Non -Inferiority of Dermis to Alloderm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Puros Dermis', 'description': 'Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.'}, {'id': 'OG001', 'title': 'Arm 2: Alloderm', 'description': 'Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.06', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '0.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Non -inferiority of Dermis to Alloderm will be assessed by comparison of the average change (from the preoperative value) in gingival recession measured at 12 months between defects receiving Puros Dermis and those receiving Alloderm.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Puros Dermis', 'description': 'Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.'}, {'id': 'FG001', 'title': 'Arm 2: Alloderm', 'description': 'Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': "Recruitment period was from 08 25 2009 to 04 24 2011. Subjects had a single non-adjacent Miller's class I or II gingival recession defect, greater than or equal to 2mm, located on the buccal aspect of the maxillary incisor, canine, or premolar. Subjects for this study were recruited from the PI's clinic.", 'preAssignmentDetails': 'Randomized'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: Puros Dermis', 'description': "Experimental treatment group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar.\n\nPuros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix)"}, {'id': 'BG001', 'title': 'Group 2: Alloderm', 'description': "Control group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar.\n\nPuros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix)"}, {'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': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.1', 'spread': '13.7', 'groupId': 'BG000'}, {'value': '47.4', 'spread': '14', 'groupId': 'BG001'}, {'value': '46.4', 'spread': '14.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-07', 'studyFirstSubmitDate': '2009-04-14', 'resultsFirstSubmitDate': '2015-05-07', 'studyFirstSubmitQcDate': '2009-04-14', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-07', 'studyFirstPostDateStruct': {'date': '2009-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non -Inferiority of Dermis to Alloderm', 'timeFrame': '12 months', 'description': 'Non -inferiority of Dermis to Alloderm will be assessed by comparison of the average change (from the preoperative value) in gingival recession measured at 12 months between defects receiving Puros Dermis and those receiving Alloderm.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['exposed Root Surface or Tooth', 'Tooth Sensitivity Miller Class I', 'Miller Class II', 'Gingival Margin'], 'conditions': ['Gingival Recession']}, 'descriptionModule': {'briefSummary': "The purpose of the study is to evaluate whether clinical parameters for Puros Dermis are, at minimum, equivalent when compared to AlloDerm, the current industry standard, for the treatment of single, non-adjacent Miller's Class I or II gingival recession.", 'detailedDescription': "This is a prospective, Post-market, Randomized, Examiner-Only Masked multi-center study to evaluate whether clinical parameters for Puros Dermis are at minimum, equivalent when compared to Alloderm, the current industry standard for the treatment of single, non-adjacent Miller's Class I or II gingival recession."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, of any ethnicity, between 18 and 99 years of age.\n* No known allergies to study material.\n* Able to communicate with the investigator and read, understand, and sign the informed consent form.\n* Maxillary incisor, canine, or premolar with at least one Miller's Class I or II gingival recession defects that are not adjacent to one another.\n* Depth of the gingival recession defects of 2mm or greater.\n* No gingival surgery within the past 12 months at the defect site. No prior antibiotic use within 3 months with less than 2 weeks durations.\n* Ability to maintain good oral hygiene.\n\nExclusion Criteria:\n\n* Patients taking any medications known to cause gingival enlargement.\n* Patients with unstable systemic diseases.\n* Patients with compromised immune systems or unstable bleeding disorders.\n* Patients with active infectious diseases (e.g. hepatitis, tuberculosis, HIV, etc.).\n* Patients with a mental disability that may hinder participation in the study (e.g. inability to follow through with oral hygiene instructions, postoperative instructions, follow-up commitments, etc.).\n* Patients taking steroid medications.\n* Tobacco use or smoking within 1 year of screening visit (e.g. cigarettes, pipes, cigars, chew).\n* Pregnant females or females attempting to get pregnant.\n* Other conditions the investigator feels would inhibit from a good candidate for the study."}, 'identificationModule': {'nctId': 'NCT00881959', 'briefTitle': 'Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'Multi-center, Post-market, Prospective, Randomized, Examiner-Only-Masked Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®', 'orgStudyIdInfo': {'id': '07-800'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Puros Dermis', 'description': "Experimental treatment group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar.", 'interventionNames': ['Device: Puros® Dermis versus Alloderm®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: Alloderm', 'description': "Control group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar.", 'interventionNames': ['Device: Puros® Dermis versus Alloderm®']}], 'interventions': [{'name': 'Puros® Dermis versus Alloderm®', 'type': 'DEVICE', 'otherNames': ['Allograft Tissue Matrix, Human Acellular Dermal Matrix (ACDM)'], 'description': 'Puros Dermis and Alloderm (both Allograft Tissue Matrix)', 'armGroupLabels': ['Group 1: Puros Dermis', 'Group 2: Alloderm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '48109-1078', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '07103-0009', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University of Medicine and Dentistry of New Jersey', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Zimmer Dental', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}