Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-27 @ 3:48 PM
Study NCT ID:
NCT01971268
Status:
UNKNOWN
Last Update Posted:
2013-10-29
First Post:
2013-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare the Success Rate of T3 Dental Implant (Biomet 3I) With or Without Platform-switch Concept
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015921', 'term': 'Dental Implants'}], 'ancestors': [{'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-23', 'studyFirstSubmitDate': '2013-10-17', 'studyFirstSubmitQcDate': '2013-10-23', 'lastUpdatePostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Position of Implant Platform to marginal bone', 'timeFrame': 'At Baseline (T0)', 'description': 'Compare marginal bone position at baseline T0 (measured radiographically (digital) from the most coronal position of marginal bone to the most coronal position of the platform, measured in the most mesial and distal part (two measures) of the implant platform.'}, {'measure': 'Marginal Bone Position at 8 Weeks', 'timeFrame': 'At 12 weeks (T1) after Baseline', 'description': 'Compare marginal bone position at T1, 12 weeks after baseline (T0) (measured radiographically (digital) from the most coronal position of marginal bone to the most coronal position of the platform, measured in the most mesial and distal part (two measures) of the implant platform'}, {'measure': 'Marginal Bone Position at 12 Weeks', 'timeFrame': 'At 18 Weeks (T2) after baseline (T0)', 'description': 'Compare marginal bone position at T2, 18 weeks from baseline (T0) (measured radiographically (digital) from the most coronal position of marginal bone to the most coronal position of the platform, measured in the most mesial and distal part (two measures) of the implant platform.'}], 'secondaryOutcomes': [{'measure': 'Osseointegration', 'timeFrame': 'At 12 weeks', 'description': 'measure the ability of the implant to integrate in bone'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['T3 dental implants', 'Marginal bone loss', 'Survival rate'], 'conditions': ['Implants', 'Bone Loss']}, 'descriptionModule': {'briefSummary': 'In patients that received a T3 (Biomet 3I) dental implant, does the use of platform-switch concept compared to the use of platform-matched concept, refrain marginal bone loss during osseointegration phase (t=12 weeks =T1) and from then to final rehabilitation (t= placement of the final restoration = at 18 weeks=T2)', 'detailedDescription': 'Patients from a private practice who received dental implants (T3 dental implant Biomet 3I) from November 2012 to October 2013 were eligible to enter the study.\n\nTwo groups were formed: one group received a T3 dental implant with platform switch concept and the other received an implant with platform matched type of connection.\n\nWe evaluate osseointegration at T1 (12 weeks) and marginal bone position in relation to the implant platform at baseline (implant installation) T0 and again at T1 and T2.\n\nFrom data recorder in T0,T1 and T2, we evaluate changes in marginal bone position.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population from a private office who seek care to replace missing teeth, must have economical status to do implant supported rehabilitations', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Single unit implant rehabilitation\n* Maxilla and mandible\n* Biomet 3I T3 dental implant placed\n* Final Rehabilitation placed\n\nExclusion Criteria:\n\n* Immediate implants\n* Radiographic impossibility of measure\n* Absence of baseline T0 radiograph\n* Smoking habits (more 10 cigarets a day)\n* Diabetes\n* Patients who receive Radio or/and Chemotherapy'}, 'identificationModule': {'nctId': 'NCT01971268', 'briefTitle': 'Compare the Success Rate of T3 Dental Implant (Biomet 3I) With or Without Platform-switch Concept', 'organization': {'class': 'OTHER', 'fullName': 'Implantology Institute'}, 'officialTitle': 'Marginal Bone Behavior of Dental Implants to Different Rehabilitation Protocols', 'orgStudyIdInfo': {'id': 'II-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Platform-Switch Group', 'description': 'T3 dental implant, with platform-switch dental implant platform concept, measure marginal bone loss', 'interventionNames': ['Device: Dental Implant', 'Device: Platform-Switch Dental Implant']}, {'label': 'Platform-Matched Group', 'description': 'T3 dental implant, platform-matched dental implant platform concept, measure marginal bone loss', 'interventionNames': ['Device: Dental Implant', 'Device: Platform-Matched dental implant']}], 'interventions': [{'name': 'Dental Implant', 'type': 'DEVICE', 'otherNames': ['Biomet 3i T3 dental implant'], 'description': 'place dental implants according to manufacturer guidelines', 'armGroupLabels': ['Platform-Matched Group', 'Platform-Switch Group']}, {'name': 'Platform-Switch Dental Implant', 'type': 'DEVICE', 'otherNames': ['Biomet 3I Dental Implant Platform-Switch', 'Discrepant Platform implant', 'non-matched dental implant'], 'description': 'Place Dental Implant with an abutment narrower than the implant platform', 'armGroupLabels': ['Platform-Switch Group']}, {'name': 'Platform-Matched dental implant', 'type': 'DEVICE', 'otherNames': ['Biomet 3I T3 Dental Implant', 'non-discrepant platform dental implant'], 'description': 'Place Dental Implant with abutment with same size as the platform', 'armGroupLabels': ['Platform-Matched Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1500-662', 'city': 'Lisbon', 'state': 'Lisbon District', 'country': 'Portugal', 'contacts': [{'name': 'Joana Velez', 'role': 'CONTACT', 'email': 'joana.velez@institutodeimplantologia.com'}, {'name': 'Andre Chen, Msc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'João Caramês, Msc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Helena Francisco, Msc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Elena Cervino, Msc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Instituto de Implantologia', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'centralContacts': [{'name': 'André Chen, Msc', 'role': 'CONTACT', 'email': 'tsouchen@gmail.com', 'phone': '00351919774343'}, {'name': 'Elena Cervino, Msc', 'role': 'CONTACT', 'email': 'elecer@gmail.com', 'phone': '00351919074338'}], 'overallOfficials': [{'name': 'Andre Chen, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Implantology Institute'}, {'name': 'João Caramês, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Implantology Institute'}, {'name': 'Helena Francisco, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Implantology Institute'}, {'name': 'Elena Cervino, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Implantology Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Implantology Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mcs', 'investigatorFullName': 'Andre Chen', 'investigatorAffiliation': 'Implantology Institute'}}}}