Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-28 @ 6:00 AM
Study NCT ID:
NCT00767169
Status:
COMPLETED
Last Update Posted:
2013-12-10
First Post:
2008-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bisphosphonate-coated Dental Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-09', 'studyFirstSubmitDate': '2008-10-03', 'studyFirstSubmitQcDate': '2008-10-03', 'lastUpdatePostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in resonance vibration frequency (ISQ units) from insertion to abutment connection as compared to the control in the same patient.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Marginal resorption on x-rays', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Edentatio (Toothlessness)'], 'conditions': ['Edentatio (Toothlessness)']}, 'referencesModule': {'references': [{'pmid': '22348981', 'type': 'RESULT', 'citation': 'Abtahi J, Tengvall P, Aspenberg P. A bisphosphonate-coating improves the fixation of metal implants in human bone. A randomized trial of dental implants. Bone. 2012 May;50(5):1148-51. doi: 10.1016/j.bone.2012.02.001. Epub 2012 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'Dental implants (screws for fastening false teeth) have been coated with bisphosphonates (drugs that slow down removal of bone). Patients get one such screw and one without coating, by a surgeon who does not know which is which. The screws are compared by measuring how well fixed they are by a vibration measuring technique, and x-rays. The hypothesis is that the bisphosphonates will improve fixation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Need for at least 2 dental implants, which are to be inserted in bone of reasonably similar quality.\n\nExclusion Criteria:\n\n* Systemic or immunologic disease, alcoholism, uncontrolled diabetes and smoking.\n* Local exclusion criteria were: previous tumour, trauma and surgery.\n* Also patients with Cawood \\& Howell class IV - VI maxilla-bone were excluded.'}, 'identificationModule': {'nctId': 'NCT00767169', 'briefTitle': 'Bisphosphonate-coated Dental Implants', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Linkoeping'}, 'orgStudyIdInfo': {'id': 'Tandskruv1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'coated implant and control', 'interventionNames': ['Device: Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate']}], 'interventions': [{'name': 'Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate', 'type': 'DEVICE', 'description': 'Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate compared with uncoated controls in the same mouth.', 'armGroupLabels': ['coated implant and control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-581 85', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Department of Oral & maxillofacial surgery, University Hospital.', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Per Aspenberg, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Linkoeping University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Per Aspenberg', 'investigatorAffiliation': 'University Hospital, Linkoeping'}}}}