Performance and Safety Use of the Mono Block Implant "KONTACT MB"
NCT ID: NCT05016258
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
159 participants
OBSERVATIONAL
2022-01-26
2025-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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KONTACT MB
Adult patients needed one or multiple implant-supported fixed restoration(s)
KONTACT MB
Dental implant surgery
Interventions
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KONTACT MB
Dental implant surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Good general health (ASA score between \[1-2\])
* Sufficient bone volume and quality (with or without bone graft) to support the implant
* Given a writing consent for the collection of his medical data as part of the study (delivery of a patient's sheet)
Exclusion Criteria
* Bruxism, parafunctional habits, occlusion disorders and / or temporomandibular joints
* Infections and oral inflammation such as periodontitis, gingivitis
* Patient with metabolic disorders (eg diabetes mellitus) or bone disease that may compromise peri-implant tissue healing
* Heavy smoker (\> 10 cigarettes / day)
* Patient with a pathology or immunosuppressive therapy such as chemotherapy, radiotherapy
* Patient on prolonged steroid therapy
* Titanium / titanium alloy allergy
* Alcohol or drug abuse
* Pregnant woman (or likely to be pregnant); or breastfeeding
* Difficulty of medical follow-up patients with geographical, social or psychological constraints
* Persons deprived of liberty or guardianship
* Involuntary / patient refusal to participate in the study
18 Years
ALL
No
Sponsors
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Biotech Dental
INDUSTRY
Responsible Party
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Principal Investigators
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Hadi Antoun
Role: PRINCIPAL_INVESTIGATOR
Hadi Antoun office
Locations
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Hadi Antoun Office
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-A01757-34
Identifier Type: -
Identifier Source: org_study_id
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