Performance and Safety Use of the Nanostructured Titanium Dental Implant KONTACT N

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter, Prospective, Observational Study on the Performance and Safety Use of the Dental Implant KONTACT N in the Current Clinical Practice

Conditions
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Dental Implant, Dental Restoration, Edentulous Alveolar Ridge, Implant-supported Fixed Prosthesis

Intervention / Treatment
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* Device: dental implant (KONTACT N)


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 Non-opposition of the patient 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

| Intervention/Treatment |
| --- |
|Device: dental implant (KONTACT N)|Implant-supported prosthetic restoration|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant success rate | Rate of implants still in function up to 12 months post-implantation and which fulfill all the predefined success criteria in the protocol. | up to 12 months post-implantation | 
| Peri-implantitis rate | Peri-implantitis is an inflammatory process affecting the tissues around the implant and causing loss of bone support (diagnosed by radiographic and clinical assessment). | 12 months post-implantation | 
| Mean osseointegration period | 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). | From the implantation up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nanostructured-implant, titanium implant, nano-roughness surface, hydrophilic surface, KONTACT N, BIOTECH DENTAL