Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-06 @ 8:47 PM
Study NCT ID:
NCT06534034
Status:
COMPLETED
Last Update Posted:
2024-08-05
First Post:
2024-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcome of Dentsply Sirona Profile Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004343', 'term': 'Drug Implants'}], 'ancestors': [{'id': 'D003692', 'term': 'Delayed-Action Preparations'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2024-07-28', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success Rate', 'timeFrame': 'through study completion, a maximum of 5 years', 'description': 'Number of dental Implants in function with no complications events'}, {'measure': 'Survival Rate', 'timeFrame': 'through study completion, a maximum of 5 years', 'description': 'Number of dental Implants in function with any complications events'}], 'secondaryOutcomes': [{'measure': 'Biological complications rate', 'timeFrame': 'through study completion, a maximum of 5 years', 'description': 'Number os dental implant treatment with some biological complication'}, {'measure': 'Mechanical complications rate', 'timeFrame': 'through study completion, a maximum of 5 year', 'description': 'Number of dental implant treatment with some mechanical complication'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental Implant', 'Complication', 'Astra Tech Osseospeed Profile'], 'conditions': ['Dental Implants']}, 'descriptionModule': {'briefSummary': 'This is a retrospective observational study of 50 implants placed between 2013 and 2023 from the same dental implant system (Osseospeed Profile, Dentsply Implants, Mölndal, Sweden).', 'detailedDescription': 'The aim of this study is to evaluate the cumulative survival, success and complication rates obtained with the use of Osseospeed Profile EV implants in two clinical centres with similar characteristics since its launch on the market in 2013, until today.\n\nAll clinical records of patients with this implant system will be collected and the following data will be recorded:\n\nPatient gender Date of placement Dimensions and location of implant(s) placed Type of implantation Design of the implant-supported dental prosthesis, single or partial, screw-retained or cemented Date of last radiographic control Type of biological and/or mechanical complications that occurred In biological complications, presence or absence of inflammatory signs and presence or absence of peri-implant bone loss.\n\nFor mechanical complications, screw loosening, porcelain fracture, fracture of the prosthetic abutment or fracture of the implant.\n\nDate of explantation if present\n\nThe mean, standard deviation (SD), and percentage will be calculated for all recorded parameters.\n\nA life table will be made with cumulative survival and success rate (CSR), according to Kaplan-Meier analysis. Correlations and regression analysis will be performed to assess the influence of the variables on the outcomes\n\nConclusions will be drawn based on the results obtained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who receive Astra Tech Osseospeed Profile dental implant system placement at two private dental clinics in Spain.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have come to private dental clinics with the need to rehabilitate a single edentulous space in the posterior mandibular area.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06534034', 'briefTitle': 'Clinical Outcome of Dentsply Sirona Profile Implants', 'organization': {'class': 'OTHER', 'fullName': 'Aula Dental Avanzada'}, 'officialTitle': 'Clinical Outcome of Dentsply Sirona Profile Implants: A 12-year Follow-up Retrospective Study.', 'orgStudyIdInfo': {'id': 'RETROPROF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Astra Tech Profile', 'description': 'Patients who has receive Astra Tech Profile dental implant system placement.', 'interventionNames': ['Procedure: Dental implant placement']}], 'interventions': [{'name': 'Dental implant placement', 'type': 'PROCEDURE', 'otherNames': ['implant surgery', 'implant prosthesis'], 'description': 'Dental implant placement on edentulous jaw.', 'armGroupLabels': ['Patients with Astra Tech Profile']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03001', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Clínica Dental Esteve', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '46021', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Clinica Dental Amigó', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Guillem Esteve-Pardo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aula Dental Avanzada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aula Dental Avanzada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Guillem Esteve-Pardo', 'investigatorAffiliation': 'Aula Dental Avanzada'}}}}