Performance and Safety Use of the Nanostructured Titanium Dental Implant "KONTACT N"
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ClinicalTrials.gov Identifier: NCT03582657
Recruitment Status : Unknown
Verified March 2019 by Biotech Dental. Recruitment status was: Recruiting
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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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Any patient who is eligible and planned for an implant-supported prosthetic restoration following the instructions for use of the KONTACT N implant and who meets the inclusion / exclusion 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)
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