Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 8:33 AM
Study NCT ID:
NCT01699568
Status:
UNKNOWN
Last Update Posted:
2013-02-15
First Post:
2012-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stability of Implants With Different Surface Treatment: Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'lastUpdateSubmitDate': '2013-02-14', 'studyFirstSubmitDate': '2012-10-01', 'studyFirstSubmitQcDate': '2012-10-01', 'lastUpdatePostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'implant loss', 'timeFrame': '4 months', 'description': 'During the osseointegration, if the implant lose his stability and if it show spin and if the patient have pain, the implant will be removed and the implant will be considered lost'}], 'secondaryOutcomes': [{'measure': 'ISQ analysis', 'timeFrame': '6 months', 'description': 'Since the implant installation, for the next 8 weeks, and after for the next 4 months, the implant stability will be measure with the Osstell, that will return a number between 0 and 100. This represents the Implant Stability Quotient (ISQ). The difference between the ISQ results will be the secondary outcome measure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dental implant stability', 'dental implant surface treatment', 'resonance frequence analysis'], 'conditions': ['Edentulous Jaws Partially']}, 'descriptionModule': {'briefSummary': "Objectives: To compare the stability of implant surface treated by dual acid etching (Porous)and implants with anodized surface (Vulcano) over a period of 16 weeks after installation.\n\nMethods: it will be a clinical study with individuals with missing teeth requiring rehabilitation with dental implants in the maxilla and that fulfill the study inclusion criteria. The research sites will be randomized into two groups: the control group patient's sites receive implant surface treated by dual acid (AR Torque Porous, Connection Implant Systems, Aruja, Brazil) and in the test group implants with anodized surface (AR Torque Vulcano-Actives, Connection Implant Systems, Aruja, Brazil). The evaluation of the stability of the implants will be made over 16 weeks, through resonance frequency analysis with Osstell (Integration Diagnostics AB, Gothenburg, Sweden). Data will be analyzed using descriptive statistics and comparative."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who have missing teeth in the maxilla,\n* over 30 years old and under 60 years old,\n* the implant sites with at least 3 months of healing after extraction,\n* the implant sites with width and length to installation of an implant of 4 mm x 10 mm.\n\nExclusion Criteria:\n\n* patients who experience any of the following conditions:\n* general contraindications for surgical procedures,\n* uncontrolled diabetes,\n* severe bruxism or clenching,\n* pregnant and lactating women,\n* active periodontal disease,\n* smoker and user of alcohol or drugs.'}, 'identificationModule': {'nctId': 'NCT01699568', 'briefTitle': 'Stability of Implants With Different Surface Treatment: Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Stability of Implants With Different Surface Treatment: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Erico1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vulcano Actives', 'description': 'Implants 4mm x 10mm Vulcano Actives (anodized surface)(AR Torque Vulcano actives), Conexão Sistemas de Prótese, Arujá, Brasil)will be placed on edentulous area in maxilla', 'interventionNames': ['Device: RFA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Porous', 'description': 'Implants 4mm x 10mm Porous (dual acid-etched surface treatment)(AR Torque Porous, Conexão Sistemas de Prótese, Arujá, Brasil)will be placed on edentulous area in maxilla', 'interventionNames': ['Device: RFA']}], 'interventions': [{'name': 'RFA', 'type': 'DEVICE', 'otherNames': ['Osstell mentor', 'resonance frequence analysis'], 'description': 'Each week since the surgery the implant stability will be measure with the Osstell mentor to verify the resonance frequence analysis, using the smartpeg number 21', 'armGroupLabels': ['Porous', 'Vulcano Actives']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Faculdade de Odontologia da USP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Érico Fraga Moreira, Master of Science', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Student of doctoral program'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master of Science', 'investigatorFullName': 'Érico Castaldin Fraga Moreira', 'investigatorAffiliation': 'University of Sao Paulo'}}}}