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

Last updated: February 7, 2023
Sponsor: Biotech Dental
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dental Filling

Treatment

N/A

Clinical Study ID

NCT05016258
2021-A01757-34
  • Ages > 18
  • All Genders

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

  • Edentulous patient (partially or completely AND formerly, recently or just beforeimplantation) requiring the placement of one (or more) dental implant (s) in maxillaryor 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

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 maycompromise 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 psychologicalconstraints
  • Persons deprived of liberty or guardianship
  • Involuntary / patient refusal to participate in the study

Study Design

Total Participants: 159
Study Start date:
January 26, 2022
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Hadi Antoun Office

    Paris, 75017
    France

    Active - Recruiting

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