Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT06623968
Status:
COMPLETED
Last Update Posted:
2024-10-03
First Post:
2024-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 39-year Follow-up Study on the World´s First Single Dental Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'targetDuration': '39 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1982-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2024-09-24', 'studyFirstSubmitQcDate': '2024-09-30', 'lastUpdatePostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '1985-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biological and technical complications', 'timeFrame': 'From enrollment in 1982 - today', 'description': 'Long-term follow-up of singel-tooth implants with regard to biological and/or technical complications'}, {'measure': 'Marginal bone level', 'timeFrame': 'from 1982 to today', 'description': 'Marginal bone level changes in mm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dental implants', 'edentulism'], 'conditions': ['Edentulism']}, 'descriptionModule': {'briefSummary': 'This is a comprehensive, long-term follow-up study of single-implant treatments. At the Brånemark Clinic in Gothenburg, Sweden, during the period of 1982-1985, 16 patients received single-tooth implants. This study evaluates the survival rate of the implants after nearly four decades, focusing on the biological and technical complications.\n\nOf the original 16 patients with a total of 23 implants, 14 patients with 19 implants were available for the follow-up and were included in the study. Clinical and radiographic examinations were performed on these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All living patient included in the original prospective study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient with diagnosis singel-tooth gap Patient with singel-tooth implants\n\nExclusion Criteria:\n\npatient with bridge constructions'}, 'identificationModule': {'nctId': 'NCT06623968', 'briefTitle': 'A 39-year Follow-up Study on the World´s First Single Dental Implants', 'organization': {'class': 'OTHER', 'fullName': 'Branemarkkliniken'}, 'officialTitle': 'A 39-year Follow-up Study on the World´s First Single Dental Implants', 'orgStudyIdInfo': {'id': 'EPN 2023-00888-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dental implants', 'type': 'PROCEDURE', 'description': 'Long-term follow-up study on singel-tooth implants'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Branemarkkliniken', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}