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

Multicenter Observational Study Evaluating the Performance and Safety of Use of the "KONTACT PERIO LEVEL" Dental Implant in Routine Clinical Practice.

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 Overview

• Status: Completed
• Conditions: Tooth Loss; Partially Edentulous Maxilla; Partially Edentulous Mandible
• Intervention / Treatment: Device: KONTACT PERIO LEVEL (KPL)

• Study Type: Observational
• Enrollment (Actual): 199

Contacts and Locations

Study Locations

• France
  • Bandol, France, 83150
    • Coordinating Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient eligible and planned for an implant-supported prosthetic restoration according to the instructions for use of the KONTACT PERIO LEVEL dental implant.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.)	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

Collaborators and Investigators

• Sponsor: Biotech Dental

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 6, 2020
• Primary Completion (ACTUAL): November 30, 2022
• Study Completion (ACTUAL): February 2, 2023

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (ACTUAL): August 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss; Mouth, Edentulous
• Other Study ID Numbers: 2020-A01491-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No