Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT05016258
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2021-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Performance and Safety Use of the Mono Block Implant "KONTACT MB"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 159}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2021-08-16', 'studyFirstSubmitQcDate': '2021-08-16', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant survival rate', 'timeFrame': 'up to 36 months', 'description': 'Number of implants still in function up to 36 months post implantation'}, {'measure': 'Peri implant bone level', 'timeFrame': 'up to 36 months', 'description': 'Bone level evolution compare to the bone level at implantation day'}, {'measure': 'Keratinized tissues level', 'timeFrame': 'up to 36 months', 'description': 'Assessment of keratinized tissues'}, {'measure': 'Gingival index', 'timeFrame': 'up to 36 months', 'description': 'Gingival index assess with Loë and Silness Score'}, {'measure': 'Bleeding index', 'timeFrame': 'up to 36 months', 'description': 'Bleeding index on probing following the Mombelli score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mono Block design', 'KONTACT MB', 'Biotech Dental'], 'conditions': ['Dentistry', 'Dental Implant', 'Dental Restoration', 'Implant-supported Fixed Prosthesis']}, 'descriptionModule': {'briefSummary': 'A multicenter prospective observational study aims to illustrate the clinical outcome of dental implants "Kontact MB" and the effects of its Mono Block design on the peri implant bone tissue recession and soft tissue conservation.\n\nAll 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 MB 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* Given a writing consent for the collection of his medical data as part of the study (delivery of a patient's sheet)\n\nExclusion Criteria:\n\n* Poor oral hygiene\n* Bruxism, parafunctional habits, occlusion disorders and / or temporomandibular joints\n* Infections and oral inflammation such as periodontitis, gingivitis\n* Patient with metabolic disorders (eg diabetes mellitus) or bone disease that may compromise peri-implant tissue healing\n* Heavy smoker (\\> 10 cigarettes / day)\n* Patient with a pathology or immunosuppressive therapy such as chemotherapy, radiotherapy\n* Patient on prolonged steroid therapy\n* Titanium / titanium alloy allergy\n* Alcohol or drug abuse\n* Pregnant woman (or likely to be pregnant); or breastfeeding\n* Difficulty of medical follow-up patients with geographical, social or psychological constraints\n* Persons deprived of liberty or guardianship\n* Involuntary / patient refusal to participate in the study"}, 'identificationModule': {'nctId': 'NCT05016258', 'briefTitle': 'Performance and Safety Use of the Mono Block Implant "KONTACT MB"', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotech Dental'}, 'officialTitle': 'Multicenter Observational Study on Performance and Safety Use of "KONTACT MB" Dental Implant in Daily Practice', 'orgStudyIdInfo': {'id': '2021-A01757-34'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'KONTACT MB', 'description': 'Adult patients needed one or multiple implant-supported fixed restoration(s)', 'interventionNames': ['Device: KONTACT MB']}], 'interventions': [{'name': 'KONTACT MB', 'type': 'DEVICE', 'otherNames': ['Biotech Dental'], 'description': 'Dental implant surgery', 'armGroupLabels': ['KONTACT MB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75017', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hadi Antoun', 'role': 'CONTACT', 'email': 'hadi@antoun.fr'}], 'facility': 'Hadi Antoun Office', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Cécile Reynès', 'role': 'CONTACT', 'email': 'c.reynes@biotech-dental.com', 'phone': '(0)626110768', 'phoneExt': '+33'}, {'name': 'Pascal Breysse', 'role': 'CONTACT', 'email': 'p.breysse@biotech-dental.com'}], 'overallOfficials': [{'name': 'Hadi Antoun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadi Antoun office'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotech Dental', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}