Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT01917305
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2013-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Platform-switching on Bone Level Alterations: a 3 Year Randomized Clinical Trial (RCT).
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2013-07-31', 'studyFirstSubmitQcDate': '2013-08-02', 'lastUpdatePostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of vertical implant bone level', 'timeFrame': 'Implant insertion (baseline), 3 months (reopening), 4 months (crown mounting), 12, 25 and 38 months'}], 'secondaryOutcomes': [{'measure': 'probing depths', 'timeFrame': '4, 8, 12, 25, 38 months'}, {'measure': 'Bleeding', 'timeFrame': 'baseline, 4, 8, 12, 25, 38 months'}, {'measure': 'Plaque', 'timeFrame': 'baseline, 4, 8, 12, 25, 38 months'}]}, 'conditionsModule': {'keywords': ['Bacteria', 'bone level', 'bone loss', 'dental implants', 'implant design', 'platform-shifting', 'platform-matching'], 'conditions': ['Periimplant Crestal Bone Level Changes']}, 'referencesModule': {'references': [{'pmid': '34352143', 'type': 'DERIVED', 'citation': 'Jervoe-Storm PM, Hablutzel AS, Bartels P, Kraus D, Jepsen S, Enkling N. Comparison of irrigation protocols for the internal decontamination of dental implants-results of in vitro and in vivo studies. Clin Oral Implants Res. 2021 Oct;32(10):1168-1175. doi: 10.1111/clr.13814. Epub 2021 Aug 27.'}, {'pmid': '24158333', 'type': 'DERIVED', 'citation': 'Enkling N, Johren P, Katsoulis J, Bayer S, Jervoe-Storm PM, Mericske-Stern R, Jepsen S. Influence of platform switching on bone-level alterations: a three-year randomized clinical trial. J Dent Res. 2013 Dec;92(12 Suppl):139S-45S. doi: 10.1177/0022034513504953. Epub 2013 Oct 24.'}]}, 'descriptionModule': {'briefSummary': 'The concept of platform-switching has been introduced to implant dentistry based on clinical observations of reduced periimplant crestal bone loss. However, published available data are controversial and most studies are limited to 12 months. The aim of the present RCT was to test the hypothesis that platform-switching has a positive impact on crestal bone level changes after 3 years.', 'detailedDescription': 'Two implants with a diameter of 4 mm were inserted crestally in the posterior mandible of 25 subjects. After three months of submerged healing, single-tooth crowns were randomly placed, either with (3.3mm platform, test) or without platform-switching (4mm platform, control). Patients were followed up at short intervals for monitoring of healing an oral hygiene. Statistical analysis for the influence of time and platform-type on bone levels employed the Brunner-Langer Model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* good general health\n* edentulous gap in the posterior mandible for placement of 2 implants\n* sufficient bone height above the alveolar nerve for placement of implants with a height of 9.5mm\n* bone width for placement of implants with diameter of 4mm\n* at least 4mm keratinized mucosa\n* medium or a thick soft tissue biotype\n\nExclusion Criteria:\n\n* infectious disease\n* diabetes or osteopathy\n* active periodontitis\n* medication influencing bone metabolism\n* lactating or pregnant women'}, 'identificationModule': {'nctId': 'NCT01917305', 'briefTitle': 'Influence of Platform-switching on Bone Level Alterations: a 3 Year Randomized Clinical Trial (RCT).', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bonn'}, 'officialTitle': 'Influence of Platform-switching on Bone Level Alterations: a 3 Year RCT.', 'orgStudyIdInfo': {'id': 'PFS3YRCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'platform-switched implant', 'description': 'platform-switched implant', 'interventionNames': ['Device: platform-shifted implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'platform-matched implant', 'description': 'platform-matched implant', 'interventionNames': ['Device: platform-shifted implant']}], 'interventions': [{'name': 'platform-shifted implant', 'type': 'DEVICE', 'armGroupLabels': ['platform-matched implant', 'platform-switched implant']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Søren Jepsen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor Dr.med Dr. med.dent MS, Chair', 'investigatorFullName': 'Søren Jepsen', 'investigatorAffiliation': 'University Hospital, Bonn'}}}}