Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT00900718
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2009-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Straumann Bone Ceramic and Bio-Oss With Guided Tissue Regeneration for Alveolar Ridge Preservation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014183', 'term': 'Transplantation, Heterologous'}], 'ancestors': [{'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-02', 'studyFirstSubmitDate': '2009-05-11', 'studyFirstSubmitQcDate': '2009-05-12', 'lastUpdatePostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The changes of bone level between baseline and 32 week post-extraction', 'timeFrame': 'baseline and 32 week post-extraction'}], 'secondaryOutcomes': [{'measure': 'implant success and survival rate', 'timeFrame': '1 year post implant loading'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bone Loss']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare a new biomaterial with an already existing treatment principle (Bio-Oss/Bio-Gide) with regard to their ability to preserve the dimensions of the alveolar ridge and to promote bone regeneration and to evaluate the early survival rate of dental implants placed in the augmented socket area and to assess radiographically and clinically changes of peri-implant soft and hard tissues.', 'detailedDescription': 'This is prospective, randomized, single-blind, controlled, single center study. The total study duration for each patient should be 12 +/- 1 month.\n\nIn total 13 visits per patient are scheduled in this study.\n\nThe study devices Straumann Bone Ceramic and Bio-Oss are CE-marked, and approved by the FDA. The products are used within the indication.\n\nOne center in the Inited Kingdom will participate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must have voluntarily signed the informed consent\n* Males and females, 18 years to 75 years of age\n* Patient needs single tooth extraction in mandibular or maxillary incisor or pre-molar region and would benefit from prosthetic reconstruction with a dental implant\n* Patients must be committed to the study and must sign informed consent\n* Patient in good general health as documented by self assessment\n\nExclusion Criteria:\n\nSystemic exclusion criteria\n\n* Patient who has any known diseases (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation\n* Female patient who are pregnant or lactating or of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence\n* Patient who are on chronic treatment (i.e., two weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine calcium antagonists, cyclosporine, and non-steroidal anti-inflammatory drugs) within one month of baseline visit\n* Patient who are on concomitant anticoagulant therapy of warfarin (coumadine), clopidogrel, ticlopidine or once daily asprin of more than 81 mg.\n* Patient who knowingly has HIV or Hepatitis\n* Physical handicaps that would interfere with the ability to perform adequate oral hygiene\n* Patient who has undergone administration of any investigational drug within 30 days of study initiation.\n* Alcoholism or chronically drug abuse causing systemic compromisation\n* Patient who is a heavy smoker (\\>10/cigarettes per day).\n* Patient is suffering from a known psychological disorder\n* Patient has limited mental capacity or language skills such that study information cannot be understood, informed consent cannot be obtained, or simple instructions cannot be followed\n\nLocal exclusion criteria\n\n* Uncontrolled or untreated periodontal disease\n* Bone defects that excludes implant restoration\n* Patient who has a full mouth plaque level \\>30 % at the enrolment visit\n* Mucosal diseases such as erosive lichen planus\n* History of local radiation therapy\n* Presence of oral lesions (such as ulceration, malignancy)\n* Severe bruxing or clenching habits\n* Persistent intraoral infection\n* Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease\n* Patient presents an acute endodontic lesion in the test tooth or in the neighbouring areas to the experimental procedure (sites with presence of an asymptomatic chronic lesion are eligible)'}, 'identificationModule': {'nctId': 'NCT00900718', 'briefTitle': 'Comparison of Straumann Bone Ceramic and Bio-Oss With Guided Tissue Regeneration for Alveolar Ridge Preservation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Institut Straumann AG'}, 'officialTitle': 'Comparison of Straumann Bone Ceramic (SBC) and Bio-Oss in Combination With Guided Tissue Regeneration (GTR) for Volume Preservation of Alveolar Ridge After Tooth Extraction: a Randomised, Single Blind, Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'CR 03/05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Straumann Bone Ceramic', 'description': 'Bone augmentation, after tooth extraction, with Straumann Bone Ceramic (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.', 'interventionNames': ['Device: Straumann Bone Ceramic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bio-Oss', 'description': 'Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide.', 'interventionNames': ['Device: Bio-Oss']}], 'interventions': [{'name': 'Straumann Bone Ceramic', 'type': 'DEVICE', 'otherNames': ['Synthetic Bone Substitute'], 'description': 'Bone augmentation, after tooth extraction, with Straumann Bone Ceramic (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.', 'armGroupLabels': ['Straumann Bone Ceramic']}, {'name': 'Bio-Oss', 'type': 'DEVICE', 'otherNames': ['Xenograft'], 'description': 'Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide.', 'armGroupLabels': ['Bio-Oss']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1X8LD', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Eastman Dental Institute, University College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Nikolaos Donos, DDS, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastman Dental Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Straumann AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}