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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Dentistry
    Dental Implant
    Dental Restoration
    Implant-supported Fixed Prosthesis

NCT05016258

Biotech Dental

27 January 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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