Performance and Safety of Use of the "KONTACT PERIO LEVEL" Transgingival Titanium Dental Implant (KPL)

Biotech Dental

Status: Completed

Conditions: Tooth Loss; Partially Edentulous Maxilla; Partially Edentulous Mandible

Treatments: Device: KONTACT PERIO LEVEL (KPL)

Study type: Observational

Funder types: Industry

Identifiers

NCT05016401

2020-A01491-38

Details and patient eligibility

About

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.

Enrollment: 199 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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