Performance and Safety Use of the Mono Block Implant "KONTACT MB"

Biotech Dental

Status

Enrolling

Conditions

Implant-supported Fixed Prosthesis

Dental Restoration

Dentistry

Dental Implant

Treatments

Device: KONTACT MB

Study type

Observational

Funder types

Industry

Identifiers

NCT05016258

2021-A01757-34

Details and patient eligibility

About

A multicenter prospective observational study aims to illustrate the clinical outcome of dental implants "Kontact MB" and the effects of its Mono Block design on the peri implant bone tissue recession and soft tissue conservation.

All the enrolled patients will be eligible for one or multiple implant-supported fixed restoration(s) according to the routine clinical practice and the manufacturer's instruction for use.

Enrollment

159 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Edentulous patient (partially or completely AND formerly, recently or just before implantation) requiring the placement of one (or more) dental implant (s) in maxillary or mandibular
Age ≥ 18 years
Good general health (ASA score between [1-2])
Sufficient bone volume and quality (with or without bone graft) to support the implant
Given a writing consent for the collection of his medical data as part of the study (delivery of a patient's sheet)

Exclusion criteria

Poor oral hygiene
Bruxism, parafunctional habits, occlusion disorders and / or temporomandibular joints
Infections and oral inflammation such as periodontitis, 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