Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-25 @ 8:38 PM
Study NCT ID:
NCT01529866
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2012-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Integration Success of an Implant System With a Novel Abutment Attachment Design in Immediate Loading Cases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014076', 'term': 'Tooth Diseases'}], 'ancestors': [{'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2012-02-07', 'studyFirstSubmitQcDate': '2012-02-08', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative success rate', 'timeFrame': '2 years', 'description': 'crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['clinical study', 'edentulism', 'dental implants', 'Nanotite Certain Tapered implant', 'randomized', 'crestal bone level', 'immediate loading'], 'conditions': ['Partial Edentulism', 'Tooth Disease']}, 'descriptionModule': {'briefSummary': 'Integration success rates measured by lack of implant mobility and crestal bone regression measurement will be higher for the experimental implant design than for the control implants.', 'detailedDescription': 'In this study patients are randomized to receive either the experimental implant system or the control Nanotite Certain Tapered (standard abutment connection) and assessed for integration success measured by cumulative success rate in cases that are loaded immediately'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients of either sex and older than 18 years of age\n* patients needing at least one dental implant to treat partial edentulism\n* patients physically able to tolerate surgical and restorative dental procedures\n* patients agreeing to all protocol visits\n\nExclusion Criteria:\n\n* patients with infection or severe inflammation at the intended treatment sites\n* patients smoking greater than 10 cigarettes per day\n* patients with uncontrolled diabetes mellitus\n* patients with uncontrolled metabolic diseases\n* patients who received radiation treatment to the head in the past 12 months\n* patients needing bone grafting at the intended treatment sites\n* patients known to be pregnant at screening visit\n* patients with para-functional habits like bruxing and clenching'}, 'identificationModule': {'nctId': 'NCT01529866', 'acronym': 'Bridge', 'briefTitle': 'Study of the Integration Success of an Implant System With a Novel Abutment Attachment Design in Immediate Loading Cases', 'organization': {'class': 'INDUSTRY', 'fullName': 'ZimVie'}, 'officialTitle': 'A Prospective Randomized-controlled Study of the Integration Success Rate of an Implant System With a Novel Abutment Attachment in Cases Loaded Immediately', 'orgStudyIdInfo': {'id': '3013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'New abutment connection implant', 'description': 'Implant with new abutment connection', 'interventionNames': ['Device: New Abutment Connection implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nanotite Certain Tapered implant', 'description': 'Nanotite Certain Tapered (standard abutment connection) implant', 'interventionNames': ['Device: Nanotite Certain Tapered implant']}], 'interventions': [{'name': 'New Abutment Connection implant', 'type': 'DEVICE', 'otherNames': ['Osseotite Endosseous dental implant'], 'description': 'New abutment connection implant', 'armGroupLabels': ['New abutment connection implant']}, {'name': 'Nanotite Certain Tapered implant', 'type': 'DEVICE', 'otherNames': ['Nanotite Endosseous dental implant'], 'description': 'Nanotite certain tapered (standard abutment connection) implant', 'armGroupLabels': ['Nanotite Certain Tapered implant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'country': 'Chile', 'facility': 'Universidad de Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Juan C Carvajal, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chile'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ZimVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}