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

February 7, 2023 updated by: Biotech Dental

Multicenter Observational Study on Performance and Safety Use of "KONTACT MB" Dental Implant in Daily Practice

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

159

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75017
        • Recruiting
        • Hadi Antoun Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 who is eligible and planned for an implant-supported prosthetic restoration following the instructions for use of the KONTACT MB implant and who meets the inclusion / exclusion criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
KONTACT MB
Adult patients needed one or multiple implant-supported fixed restoration(s)
Device: KONTACT MB
Dental implant surgery
Other Names:
  • Biotech Dental

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant survival rate
Time Frame: up to 36 months
Number of implants still in function up to 36 months post implantation
up to 36 months
Peri implant bone level
Time Frame: up to 36 months
Bone level evolution compare to the bone level at implantation day
up to 36 months
Keratinized tissues level
Time Frame: up to 36 months
Assessment of keratinized tissues
up to 36 months
Gingival index
Time Frame: up to 36 months
Gingival index assess with Loë and Silness Score
up to 36 months
Bleeding index
Time Frame: up to 36 months
Bleeding index on probing following the Mombelli score
up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotech Dental

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 26, 2022

Primary Completion (ANTICIPATED)

February 1, 2023

Study Completion (ANTICIPATED)

October 1, 2025

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

August 16, 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

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021-A01757-34

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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