Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KONTACT PERIO LEVEL (KPL) | Device | The Kontactâ„¢ Perio Level is an implant with a transgingival neck that facilitates one-step surgery. |
| 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 |
| 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.) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Any patient eligible and planned for an implant-supported prosthetic restoration according to the instructions for use of the KONTACT PERIO LEVEL dental implant.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coordinating Investigator | Bandol | 83150 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |