Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-24 @ 3:33 AM
Study NCT ID:
NCT01902056
Status:
COMPLETED
Last Update Posted:
2013-07-17
First Post:
2013-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C440568', 'term': 'Alloderm'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-15', 'studyFirstSubmitDate': '2013-07-07', 'studyFirstSubmitQcDate': '2013-07-15', 'lastUpdatePostDateStruct': {'date': '2013-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Soft tissue thickness.', 'timeFrame': '4 months', 'description': 'Determining the soft tissue thickness using a tissue probe.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['allograft', 'acellular dermal matrix', 'Alloderm'], 'conditions': ['Clinical Efficacy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effect on soft tissue thickness of placing either a single or double layer of acellular dermal matrix simultaneous with dental implant placement. The hypothesis is that 2 layers of acellular dermal matrix will produce thicker tissues that one layer.', 'detailedDescription': 'Patients must be greater that 18 years old, not pregnant, and have an edentulous space with a tooth on each side that is treatment planned to receive a dental implant. The primary outcome measure is soft tissue thickness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: The inclusion criteria were;\n\n1. one edentulous site bordered by 2 teeth in the maxilla or mandible from first molar to first molar treatment planned to receive an implant\n2. at least 18 years of age\n3. must sign the informed consent -\n\nExclusion Criteria: The exclusion criteria included:\n\n1. uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium\n2. previous head and neck radiation\n3. oral bisphosphonates for \\> 3 years or any IV bisphosphonates\n4. smoking \\> 1/2 pack per day or other tobacco habits that might interfere with soft tissue healing\n5. requirement for prophylactic antibiotics\n6. allergies to any medication or material used in the study, or that would adversely affect study procedures\n7. chemotherapy in the previous 12 months\n8. psychological problems that would interfere with treatment\n9. patients unable or unwilling to sign the informed consent\n10. pregnancy -'}, 'identificationModule': {'nctId': 'NCT01902056', 'briefTitle': 'Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix: A Randomized, Controlled Clinical Tria.', 'orgStudyIdInfo': {'id': '12.0330'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'one layer allograft', 'description': 'One layer allograft as a positive control', 'interventionNames': ['Procedure: One layer allograft']}, {'type': 'EXPERIMENTAL', 'label': 'Two layer allograft', 'description': 'Two layer allograft as the test group.', 'interventionNames': ['Procedure: Two layer allograft']}], 'interventions': [{'name': 'One layer allograft', 'type': 'PROCEDURE', 'otherNames': ['One layer of acellular dermal matrix (Alloderm).'], 'description': 'The acellular dermal matrix was placed on the facial surface.', 'armGroupLabels': ['one layer allograft']}, {'name': 'Two layer allograft', 'type': 'PROCEDURE', 'otherNames': ['Two layers of acellular dermal matrix (Alloderm).'], 'description': 'The acellular dermal matrix was placed on the facial surface.', 'armGroupLabels': ['Two layer allograft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Graduate Periodontics Clinic, School of Dentistry, University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Henry Greenwell, DMD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Louisville'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Henry Greenwell', 'investigatorAffiliation': 'University of Louisville'}}}}