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

Tooth Loss Clinical Trial

— KPL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05016401
• Other study ID #: 2020-A01491-38
• Status: Completed
• Start date: November 6, 2020
• Est. completion date: February 2, 2023

Study information

• Verified date: August 2021
• Source: Biotech Dental
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: February 2, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mouth, Edentulous
• Partially Edentulous Mandible
• Partially Edentulous Maxilla
• Tooth Loss

Intervention

Device:
• KONTACT PERIO LEVEL (KPL)
The Kontact™ Perio Level is an implant with a transgingival neck that facilitates one-step surgery.

Locations

Country	Name	City	State
France	Coordinating Investigator	Bandol

Sponsors (1)

Lead Sponsor	Collaborator
Biotech Dental

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bone Level	Peri-implant marginal bone loss and / or regrowth is calculated using x-rays	12 months
Secondary	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
Secondary	Primary stability	Value of the torque during implant placement	surgical time
Secondary	Survival rate	An implant is classified as "surviving" if it is still in operation at some point t	12 months
Secondary	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
Secondary	Peri-implantitis	Number of peri-implantitis (inflammatory disease causing bone loss around an implant)	12 months
Secondary	Quality of Life	Evolution of the quality of life score calculated using GOHAI (General Oral Health Assessment Index)	12 months