Performance and Safety Use of the Nanostructured Titanium Dental Implant "KONTACT N"

A multicenter prospective observational study in which aim is to illustrate the clinical outcome of dental implants "Kontact N"; and the effects of its nanostructured surface on the osseointegration and secondary stability without increasing the rate of peri-implantitis. 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.

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Key information

Conditions

Dental Implant Dental Restoration Edentulous Alveolar Ridge Implant-supported Fixed Prosthesis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr KHOURY Elias

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
Non-opposition of the patient 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

Treatment and study plan

dental implant (KONTACT N)

Device

Implant-supported prosthetic restoration

Other names: KONTACT N, BIOTECH DENTAL

Primary outcomes

Implant success rate

Time frame: up to 12 months post-implantation

Rate of implants still in function up to 12 months post-implantation and which fulfill all the predefined success criteria in the protocol.
Peri-implantitis rate

Time frame: 12 months post-implantation

Peri-implantitis is an inflammatory process affecting the tissues around the implant and causing loss of bone support (diagnosed by radiographic and clinical assessment).
Mean osseointegration period

Time frame: From the implantation up to 12 months

Period from which a direct structural and functional junction can be observed between the remodeled living bone and the implant surface (by clinical and radiographic assessment).

Sponsors and collaborators

Lead sponsor

Biotech Dental

Industry

Registry information

Official study title

Multicenter, Prospective, Observational Study on the Performance and Safety Use of the Dental Implant "KONTACT N" in the Current Clinical Practice

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2022
First posted: Jul 11, 2018
Registry last updated: Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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