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

NCT ID: NCT05016401

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-06

Study Completion Date

2023-02-02

Brief Summary

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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.

Detailed Description

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Conditions

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Tooth Loss Partially Edentulous Maxilla Partially Edentulous Mandible

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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KONTACT PERIO LEVEL (KPL)

The Kontact™ Perio Level is an implant with a transgingival neck that facilitates one-step surgery.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotech Dental

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Coordinating Investigator

Bandol, , France

Site Status

Countries

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France

Other Identifiers

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2020-A01491-38

Identifier Type: -

Identifier Source: org_study_id

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