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

Completed

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

• Registration Number: NCT05016401
• Lead Sponsor: Biotech Dental

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-06
• Status Verified: 2021-08
• Study First Submitted: 2021-08-17
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-23
• Primary Completion: 2022-11-30
• Study Completion: 2023-02-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Bone Level	12 months	Peri-implant marginal bone loss and / or regrowth is calculated using x-rays
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
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;...
Quality of Life	12 months	Evolution of the quality of life score calculated using GOHAI (General Oral Health Assessment Index)
Peri-implantitis	12 months	Number of peri-implantitis (inflammatory disease causing bone loss around an implant)

Trial Locations

Locations (1)

Coordinating Investigator; 🇫🇷 Bandol, France