Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT00835432
Status:
COMPLETED
Last Update Posted:
2009-02-03
First Post:
2009-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Morphometric, Clinical and Histological Study on One Stage Bone Augmentation Using BoneCeramic (BCP) and Collagen Membranes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-02', 'studyFirstSubmitDate': '2009-02-02', 'studyFirstSubmitQcDate': '2009-02-02', 'lastUpdatePostDateStruct': {'date': '2009-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alteration in width of alveolar bone at implant location after augmentation in mm', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Histomorphometry in regard to areas occupied by bone to soft tissue to grafting material', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lateral augmentation', 'GBR', 'BoneCeramic', 'collagen membrane', 'histomorphometry', 'morphometry', 'reentry', 'biopsy'], 'conditions': ['Dehiscent Type of Alveolar Bone Defect', 'One Stage Bone Augmentation']}, 'descriptionModule': {'briefSummary': 'Prospective randomized assessment of alveolar ridge alterations after augmenting dehisced areas by applying principles of guided bone regeneration (GBR) subsequently to implant installation.\n\nOssix as cross-linked and BioGide as non cross-linked degradable collagen membranes, both used in combination with biphasic Calcium-Phosphate (BoneCeramic) as bone substitute. Clinical measurements and impressions from the sites of interest are to be taken at the stage of augmentation and 6 months after. At six months re-entry non-standardized biopsies from augmented sites will be taken to determine newly grown tissue in quality and quantity.\n\nDue to different degradation characteristics of the two collagen membranes used as barrier, amount of newly formed mineralized tissue is suspected to vary in tests and controls, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* alveolar ridge deficiences after tooth loss\n\nExclusion Criteria:\n\n* systemic disorders (diabetes mellitus, morbus crown, etc.)\n* pregnancy or lactating period'}, 'identificationModule': {'nctId': 'NCT00835432', 'acronym': 'BCP+Collagen', 'briefTitle': 'Morphometric, Clinical and Histological Study on One Stage Bone Augmentation Using BoneCeramic (BCP) and Collagen Membranes', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Prospective Clinical, Morphometric and Histological Study on Augmentation Using BoneCeramic as Bone Substitute in Combination With Either Cross-Linked or Non Cross-Linked Collagen Membrane in Dehiscent Type of Defects .', 'orgStudyIdInfo': {'id': 'EA/2/054'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ossix', 'type': 'DEVICE', 'otherNames': ['cross-linked collagen membrane barrier'], 'description': 'Test group'}, {'name': 'Biogide', 'type': 'DEVICE', 'otherNames': ['non cross-linked collagen membrane barrier'], 'description': 'controls'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anton Friedmann, Dr., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Periodontology Charité Center3 CBF, Assmannshauser Str. 4-6, 14197 Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Anton Friedmann', 'oldOrganization': 'Department of Periodontology, Charité Center 3, Berlin, Germany'}}}}