Performance and Safety Use of the Mono Block Implant KONTACT MB

Study Overview
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Brief Summary
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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. 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.

Official Title
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Multicenter Observational Study on Performance and Safety Use of KONTACT MB Dental Implant in Daily Practice

Conditions
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Dentistry, Dental Implant, Dental Restoration, Implant-supported Fixed Prosthesis

Intervention / Treatment
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* Device: KONTACT MB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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: Poor oral hygiene 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| KONTACT MB<br>Adult patients needed one or multiple implant-supported fixed restoration(s) | Device: KONTACT MB<br>* Dental implant surgery<br>* Other names: Biotech Dental;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival rate | Number of implants still in function up to 36 months post implantation | up to 36 months | 
| Peri implant bone level | Bone level evolution compare to the bone level at implantation day | up to 36 months | 
| Keratinized tissues level | Assessment of keratinized tissues | up to 36 months | 
| Gingival index | Gingival index assess with Loë and Silness Score | up to 36 months | 
| Bleeding index | Bleeding index on probing following the Mombelli score | up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mono Block design, KONTACT MB, Biotech Dental