Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-01-02 @ 12:13 AM
Study NCT ID:
NCT03582657
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2018-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance and Safety Use of the Nanostructured Titanium Dental Implant "KONTACT N"
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-01', 'studyFirstSubmitDate': '2018-06-15', 'studyFirstSubmitQcDate': '2018-07-10', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant success rate', 'timeFrame': 'up to 12 months post-implantation', 'description': 'Rate of implants still in function up to 12 months post-implantation and which fulfill all the predefined success criteria in the protocol.'}, {'measure': 'Peri-implantitis rate', 'timeFrame': '12 months post-implantation', 'description': 'Peri-implantitis is an inflammatory process affecting the tissues around the implant and causing loss of bone support (diagnosed by radiographic and clinical assessment).'}, {'measure': 'Mean osseointegration period', 'timeFrame': 'From the implantation up to 12 months', 'description': 'Period from which a direct structural and functional junction can be observed between the remodeled living bone and the implant surface (by clinical and radiographic assessment).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nanostructured-implant', 'titanium implant', 'nano-roughness surface', 'hydrophilic surface', 'KONTACT N', 'BIOTECH DENTAL'], 'conditions': ['Dental Implant', 'Dental Restoration', 'Edentulous Alveolar Ridge', 'Implant-supported Fixed Prosthesis']}, 'descriptionModule': {'briefSummary': 'A multicenter prospective observational study in which aim is to illustrate the clinical outcome of dental implants "Kontact N"; and the effects of its nanostructured surface on the osseointegration and secondary stability without increasing the rate of peri-implantitis. All the enrolled patients will be eligible for one or multiple implant-supported fixed restoration(s) according to the routine clinical practice and the manufacturer\'s instruction for use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient who is eligible and planned for an implant-supported prosthetic restoration following the instructions for use of the KONTACT N implant and who meets the inclusion / exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Edentulous patient (partially or completely AND formerly, recently or just before implantation) requiring the placement of one (or more) dental implant (s) in maxillary or mandibular\n* Age ≥ 18 years\n* Good general health (ASA score between \\[1-2\\])\n* Sufficient bone volume and quality (with or without bone graft) to support the implant\n* Non-opposition of the patient for the collection of his medical data as part of the study (delivery of a patient's sheet)\n\nExclusion Criteria:\n\n1. Poor oral hygiene\n2. Bruxism, parafunctional habits, occlusion disorders and / or temporomandibular joints\n3. Infections and oral inflammation such as periodontitis, gingivitis\n4. Patient with metabolic disorders (eg diabetes mellitus) or bone disease that may compromise peri-implant tissue healing\n5. Heavy smoker (\\> 10 cigarettes / day)\n6. Patient with a pathology or immunosuppressive therapy such as chemotherapy, radiotherapy\n7. Patient on prolonged steroid therapy\n8. Titanium / titanium alloy allergy\n9. Alcohol or drug abuse\n10. Pregnant woman (or likely to be pregnant); or breastfeeding\n11. Difficulty of medical follow-up patients with geographical, social or psychological constraints\n12. Persons deprived of liberty or guardianship\n13. Involuntary / patient refusal to participate in the study"}, 'identificationModule': {'nctId': 'NCT03582657', 'briefTitle': 'Performance and Safety Use of the Nanostructured Titanium Dental Implant "KONTACT N"', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotech Dental'}, 'officialTitle': 'Multicenter, Prospective, Observational Study on the Performance and Safety Use of the Dental Implant "KONTACT N" in the Current Clinical Practice', 'orgStudyIdInfo': {'id': '2018-A00194-51'}}, 'armsInterventionsModule': {'interventions': [{'name': 'dental implant (KONTACT N)', 'type': 'DEVICE', 'otherNames': ['KONTACT N', 'BIOTECH DENTAL'], 'description': 'Implant-supported prosthetic restoration'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Dr KHOURY Elias', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'KHOURY, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotech Dental', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}