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.
Study Type
OBSERVATIONAL
Enrollment
199
The Kontact™ Perio Level is an implant with a transgingival neck that facilitates one-step surgery.
Coordinating Investigator
Bandol, France
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
Time frame: 12 months
Bone Level
Peri-implant marginal bone loss and / or regrowth is calculated using x-rays
Time frame: 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.)
Time frame: 12 months
Primary stability
Value of the torque during implant placement
Time frame: surgical time
Survival rate
An implant is classified as "surviving" if it is still in operation at some point t
Time frame: 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;...
Time frame: 12 months
Peri-implantitis
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Number of peri-implantitis (inflammatory disease causing bone loss around an implant)
Time frame: 12 months
Quality of Life
Evolution of the quality of life score calculated using GOHAI (General Oral Health Assessment Index)
Time frame: 12 months