Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-24 @ 9:05 PM
Study NCT ID:
NCT02703168
Status:
COMPLETED
Last Update Posted:
2016-03-09
First Post:
2015-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Performance of SLActive Implants After Immediate or Early Loading
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-03', 'studyFirstSubmitDate': '2015-09-11', 'studyFirstSubmitQcDate': '2016-03-03', 'lastUpdatePostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Crestal bone level change by radiographic assessment', 'timeFrame': '8 and 10 year post-surgery', 'description': 'To evaluate the changes in crestal bone levels (in millimetre) in relation to defined implant reference point and different time points (between baseline at implant insertion and follow-up time points at 8 and 10 years after implant insertion) in the maxilla and mandible of the immediate and early loading groups.'}], 'secondaryOutcomes': [{'measure': 'Implant survival by clinical and radiographic assessment', 'timeFrame': '8 and 10 year post-surgery', 'description': "To evaluate the implant survival rate by clinically and radiographically count of implants still in place in the subject's jaw bone at the time of assessment (8 and 10 years post-surgery). The implant survival rates will be compared between the treatment groups (immediate loading and early loading)."}, {'measure': 'Incidence of adverse events and adverse device effects', 'timeFrame': '8 and 10 year post-surgery', 'description': 'Total number of AEs and total number of AEs related to the study treatment (device-related or procedure-related), as well as the total number of subjects affected by at least one adverse event wil be calculated per treatment group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dental implants'], 'conditions': ['Partial Edentulism']}, 'descriptionModule': {'briefSummary': 'This is a follow-up study with patients, who participated in the Straumann clinical study CR06/03. The objective is the assessment of long-term data (8 and 10 years after implantation) on the performance of immediate and early (28-34 days post implantation) non-occlusal loaded Straumann Tissue Level Implants with SLActive surface when used to support single crowns or 2-4 unit fixed dental prostheses in the posterior maxilla and mandible.\n\nThe primary objective is of the study is to analyse the change in crestal bone levels 8 and 10 years post-surgery compared to 6 months, 1 year, 2 years and 3 years post-surgery in the immediate and early loading group.', 'detailedDescription': 'This is a prospective, post-market, open label, follow-up multicenter study with patients who participated in the Straumann clinical study CR06/03. The total study duration for each patient should be 2 years.\n\nIn total 2 visits are scheduled in this study. Bone level changes, implant success and survival, performance of the restorative components, and adverse events (AEs) will be assessed.\n\nThe study device is a CE-marked product and FDA approved.\n\nThree centres, one in Portugal and two in Germany, will participate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who participated in the Straumann clinical trial CR06/03', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed Written Informed Consent\n* Patients with Straumann SLActive tissue level implants, who participated in the Straumann CR06/03 clinical study.\n* Patients must be committed to the study for its full duration.\n* Patient's Radiographic stent must be available from study CR06/03\n\nExclusion Criteria:\n\n* Use of any investigational drug or device within 30 days before start of the study.\n* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with the analysis of the study results, such as history of non-compliance"}, 'identificationModule': {'nctId': 'NCT02703168', 'briefTitle': 'Long-term Performance of SLActive Implants After Immediate or Early Loading', 'organization': {'class': 'INDUSTRY', 'fullName': 'Institut Straumann AG'}, 'officialTitle': 'Post-marketing Study to Document Long-term Performance of Straumann Tissue Level Implants With SLActive Surface in the Posterior Mandible and Maxilla After Immediate or Early Loading - Follow-up to Study CR 06/03', 'orgStudyIdInfo': {'id': 'CR 03-05/11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Immediate loading', 'description': 'Patients were allocated to treatment group in the core study. Immediate loading was defined as follows: Implant(s) will be restored with a temporary restoration on the day of surgery'}, {'label': 'Early loading', 'description': 'Patients were allocated to treatment group in the core study. Early loading was defined as follows: Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Joachim Jackowski, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universität Witten/Herdecke'}, {'name': 'Tim Krafft, Dr. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kieferchirurgische Praxisgemeinschaft, Weiden'}, {'name': 'Pedro Nicolau, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Coimbra'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Straumann AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}