Partially Edentulous Mandible, Partially Edentulous Maxilla, Tooth Loss
Conditions
Brief summary
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.
Interventions
DEVICEKONTACT PERIO LEVEL (KPL)
The Kontact™ Perio Level is an implant with a transgingival neck that facilitates one-step surgery.
Sponsors
Biotech Dental
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prosthetic complications | 12 months | 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.) |
| Primary stability | surgical time | Value of the torque during implant placement |
| Survival rate | 12 months | An implant is classified as surviving if it is still in operation at some point t |
| Bone Level | 12 months | Peri-implant marginal bone loss and / or regrowth is calculated using x-rays |
| Peri-implantitis | 12 months | Number of peri-implantitis (inflammatory disease causing bone loss around an implant) |
| Quality of Life | 12 months | Evolution of the quality of life score calculated using GOHAI (General Oral Health Assessment Index) |
| Factors that influence the survival and success rate | 12 months | 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;... |
Countries
France
Outcome results
None listed