Performance and Safety of Use of the KONTACT PERIO LEVEL Transgingival Titanium Dental Implant

Study Overview
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Brief Summary
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As part of post-marketing clinical follow-up, BIOTECH DENTAL sets up the collection and evaluation of clinical data proactively with the aim of confirming the safety, performance as well as the constantly acceptable nature of the risks identified and of detecting potential emerging risks with the use of Kontact Perio Level implants in everyday practice.

Official Title
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Multicenter Observational Study Evaluating the Performance and Safety of Use of the KONTACT PERIO LEVEL Dental Implant in Routine Clinical Practice.

Conditions
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Tooth Loss, Partially Edentulous Maxilla, Partially Edentulous Mandible

Intervention / Treatment
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* Device: KONTACT PERIO LEVEL (KPL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Edentulous patient requiring the placement of one (or more) dental implant (s) in the maxilla or mandibular Age ≥ 18 years old Good general health (ASA score between [1-2]) Sufficient volume and bone quality (with or without bone graft) to support the implant Non-objection of the patient for the collection of his medical data as part of the study Exclusion Criteria: Poor oral hygiene Bruxism, parafunctional habits, occlusion disorders and / or temporomandibular joints Infections and oral inflammation such as active periodontitis, active 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: KONTACT PERIO LEVEL (KPL)|The Kontact™ Perio Level is an implant with a transgingival neck that facilitates one-step surgery.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | For an implant to be declared successful it must meet the following criteria as defined by Albrektsson et al. 1986 adapted: Lack of mobility ; Absence of pain ; Lack of radiolucency around the implant ; Absence of bleeding and inflammation ; No significant peri-implant periodontal pocket (≤4mm) ; Stability of the peri-implant bone level over time with marginal bone loss ≤1.5 mm the first year and ≤0.2 mm the following years | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Level | Peri-implant marginal bone loss and / or regrowth is calculated using x-rays | 12 months | 
| Prosthetic complications | All prosthetic complications having affected the restorations on implants, from the placement of the provisional restorations until the end of the study, are recorded (loosening of the abutment screws, the fracture of the abutment, loss of retention, fracture, etc.) | 12 months | 
| Primary stability | Value of the torque during implant placement | surgical time | 
| Survival rate | An implant is classified as surviving if it is still in operation at some point t | 12 months | 
| Factors that influence the survival and success rate | Univariate statistical analysis of the success and survival rate as a function of: age; sex; bone density; site of implantation; bone graft; type of prosthesis; jaw type;... | 12 months | 
| Peri-implantitis | Number of peri-implantitis (inflammatory disease causing bone loss around an implant) | 12 months | 
| Quality of Life | Evolution of the quality of life score calculated using GOHAI (General Oral Health Assessment Index) | 12 months |