Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-30 @ 5:44 AM
Study NCT ID:
NCT04960904
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2021-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Performance and Safety in the Medium and Long Term of Global D Implant-prosthetic Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 514}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2021-06-30', 'studyFirstSubmitQcDate': '2021-07-07', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': '5 years', 'description': 'Survival rate at 5 years, 7/8 years and 10 years minimum defined by the rate of implants in situ'}], 'secondaryOutcomes': [{'measure': 'Implant system stability', 'timeFrame': '1-4 month, 6-12 month, 5 years, 7/8 years and 10 years after surgery', 'description': 'Implant system stability of all follow-up visits. Stability of the implant system is assessed by the investigator at each visit. The variable collected is YES for stable implant and NO for unstable implant.'}, {'measure': 'The success rate', 'timeFrame': '5 years, 7/8 years, 10 years', 'description': 'The success rate at 5 years, 7/8 years and 10 years defined by the rate of stable implants without pain or sensitivity at the implant level, with the absence of peri-implantitis and osteolysis;'}, {'measure': 'Appearance of the gum', 'timeFrame': '5 years, 7/8 years, 10 years', 'description': 'Appearance of the gum based on the visual appearance of the gum will be collected. Several choices are possible: Inflammation / Gingival recession / Absence of keratinized tissue band around the crown'}, {'measure': 'Adverse events and complications', 'timeFrame': 'Up to 5 years, 7/8 years, and 10 years of follow-up', 'description': 'Nature, number, severity and degree of relationship of adverse events, serious or not, reported as implant-related or unrelated for non-serious adverse events, immediate or delayed at all visits'}, {'measure': 'Score of Quality of life (OHIP-14 - The Oral Health Impact Profile)', 'timeFrame': '5 years, 7/8 years, 10 years', 'description': "The score obtained from the satisfaction and quality of life questionnaire (OHIP-14) at 5 years The Oral Health Impact Profile 14 (OHIP-14) \\[14\\] is a questionnaire measuring the impact of the prosthetic restoration on the patient's well-being and quality of life. The patient answers fourteen questions grouped into seven domains (functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap) . For each question, the patient can answer with one of the following values: never:0, almost never:1, occasionally:2, quite often:3, very often:4. The sum of the values for each question gives a score that can vary from 0 to 56. A high score reflects a high level of discomfort."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dental implant', 'survival rate', 'performance'], 'conditions': ['Dental Implants']}, 'descriptionModule': {'briefSummary': 'This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety in the medium and long term of implant-prosthetic systems including Global D dental implants: In-Kone® UNIVERSAL, In-Kone® PRIMO, twinKon®, EVL® S, EVL® K and EVL® C.', 'detailedDescription': "Study design: Ambispective multi-center observational study, on a single patient group per implant, constituting a consecutive and exhaustive series of subjects, without selection.\n\nInvestigators:Twelve centers participated to the study in France and one in Greece.\n\nThe objectives are evaluate the 5-year follow-up performance and safety of Global D dental implant ranges, which consist of collecting data at a 5-year follow-up visit (prospectively or retrospectively). All previous data is collected retrospectively from the patient's file. The study has been extended to 7/8 years and up to 10 years follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult male or female patients who have had dental implant surgery. In the perspective of being able to obtain follow-up data at least 5 years and up to 10 years and the series to be continuous and exhaustive, the implantation period will be limited from\n\n* October 1, 2013 to June 30, 2015 for EVL® S, EVL® K and EVL® C, In-Kone® UNIVERSAL and In-Kone® PRIMO implants\n* January 1, 2013 to June 30, 2015 for twinKon® implants', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* Major (s) at the time of the implantation\n* Having needed implant surgery with one or more Global D devices:\n* between October 1, 2013 - June 30, 2015 for EVL® S, EVL® K and EVL® C, In-Kone® UNIVERSAL and In-Kone® PRIMO implants\n* between January 1, 2013 - June 30, 2015 for twinKon® implants\n* Affiliated or benefiting from French Social Security\n* Not opposing the use of their data\n* Having carried out his annual follow-up visit at 5, 7/8 and 10 years or any other visit motivated by the removal of the implant during the 10 years\n\nExclusion Criteria:\n\n* Patient unable to understand information related to his/her participation in the study\n* Deceased patient, date of death after the date of implantation'}, 'identificationModule': {'nctId': 'NCT04960904', 'briefTitle': 'Study Evaluating the Performance and Safety in the Medium and Long Term of Global D Implant-prosthetic Systems', 'organization': {'class': 'INDUSTRY', 'fullName': 'Global D'}, 'officialTitle': 'Study Evaluating the Performance and Safety in the Medium and Long Term of Implant-prosthetic Systems Including Ranges of Dental Implants and Prosthetic Components Global D: In-Kone® U,In-Kone® P,twinKon®,EVL® S,EVL® K,EVL® C', 'orgStudyIdInfo': {'id': '1905-G-IMP-DENT-R'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'In-Kone® UNIVERSAL', 'description': 'Implant-prosthetic systems made with dental implants and prosthetic components of the ranges In-Kone® UNIVERSAL, including the former 3.0 range now named In-Kone® Universal NR (narrow), and including the In-Kone® Universal WD (wide).', 'interventionNames': ['Device: Dental implant surgery with implants']}, {'label': 'In-Kone® PRIMO', 'description': 'Implant-prosthetic systems made with dental implants and prosthetic components of the ranges In-Kone® PRIMO', 'interventionNames': ['Device: Dental implant surgery with implants']}, {'label': 'twinKon®', 'description': 'Implant-prosthetic systems made with dental implants and prosthetic components of the ranges twinKon®', 'interventionNames': ['Device: Dental implant surgery with implants']}, {'label': 'EVL® S', 'description': 'Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® S', 'interventionNames': ['Device: Dental implant surgery with implants']}, {'label': 'EVL® K', 'description': 'Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® K', 'interventionNames': ['Device: Dental implant surgery with implants']}, {'label': 'EVL® C', 'description': 'Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® C', 'interventionNames': ['Device: Dental implant surgery with implants']}], 'interventions': [{'name': 'Dental implant surgery with implants', 'type': 'DEVICE', 'description': 'Adult patients who have had dental implant surgery.', 'armGroupLabels': ['EVL® C', 'EVL® K', 'EVL® S', 'In-Kone® PRIMO', 'In-Kone® UNIVERSAL', 'twinKon®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42160', 'city': 'Andrézieux-Bouthéon', 'status': 'COMPLETED', 'country': 'France', 'facility': 'Dental practice', 'geoPoint': {'lat': 45.52625, 'lon': 4.26021}}, {'zip': '15123', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'facility': 'Dental practice', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Nathalie TRETOUT', 'role': 'CONTACT', 'email': 'n.tretout@globald.com', 'phone': '0478569700'}], 'overallOfficials': [{'name': 'Jean Pierre AXIOTIS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dental surgeon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Global D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}