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A Clinical Study on Implants With TiUltra Technology and Associated Prosthetic Components
Sponsor: Nobel Biocare
Summary
This is a multicenter, prospective, non-interventional study in which a total of 1000 subjects in need of a single, multiple or full arch restoration in any region of the mouth (healed or extracted) will be treated in up to 30 study centers. The primary aim of this study is to demonstrate non-inferiority of all NobelBiocare TiUltra implants to historic data from NobelActive TiUnite coated implant in terms of marginal bone level change over 5 years after final prosthetic delivery. Eligible subjects who provide their informed consent for participation will be enrolled into one of four groups, each sized to 250 individuals. They will be treated with the corresponding implant system assigned to the group. The allocation into a certain group is only driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Each subject will be followed for 5 years after definitive prosthetic placement
Official title: A Prospective, Non-interventional, Clinical Study to Evaluate the Safety, Performance and Clinical Benefits of Implants With TiUltra Technology and Associated Prosthetic Components
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2021-05-26
Completion Date
2029-05-31
Last Updated
2025-05-25
Healthy Volunteers
No
Conditions
Interventions
NobelActive TiUltra implant
Subjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic.
NobelParallel CC TiUltra implants
Subjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic.
NobelReplace CC TiUltra implants
Subjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic.
Nobel Biocare N1 TiUltra TCC implants
Subjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic.
Locations (32)
Madison Prosthodontics
Madison, Alabama, United States
Northwest Oral and Maxillofacial Surgery
Arlington Heights, Illinois, United States
Midwest Dental Implantology
Saint Charles, Illinois, United States
New York Center for Orthognathic and Maxillofacial Surgery
New York, New York, United States
Periodontal Associates
Tualatin, Oregon, United States
Dentartisans Pty ltd
Pyrmont, New South Wales, Australia
Bc Prosthodontics
West Perth, Perth, Australia
Melbourne Dental School The University of Melbourne
Melbourne, Australia
Akademie für orale Implantologie GmbH & Co
Vienna, Austria
Implantologie und Ästhetische Zahnheilkunde
Vienna, Austria
Herning Implantat Center
Herning, Herning, Denmark
Dental Center Helmiäinen
Tampere, Finland
Cabinet du Dr Noharet
Lyon, France
BGLP
Montpellier, France
IFCIA
Paris, France
DrS - Schöne Zähne - Dr. Scherg Praxis für Implantologie & Ästhetik
Karlstadt am Main, Germany
Studio Odontoiatrico Specialistico Ban Mancini Fabbri
Cattolica, Italy
UOC di Chirurgia Maxillo-Facciale e Odontoiatria
Verona, Italy
Staas & Bergmans Zorgvooruwmond B.V.
's-Hertogenbosch, Netherlands
ParoBrea- Parodontologie & Implantologie
Breda, Netherlands
Department of Oral and Maxillofacial Surgery University Medical Center Groningen
Groningen, Netherlands
The Oris Dental Harstad
Harstad, Norway
Maló Clinic
Lisbon, Portugal
Clinica Lluch
Barcelona, Spain
Clinica Dental Crooke & Laguna
Málaga, Spain
Altés & Mesquida
Palma de Mallorca, Spain
Folktandvården Västra Götaland, Brånemarkkliniken
Gothenburg, Sweden
Pequrio AB
Malmo, Sweden
Dentalspecialist
Egerkingen, Switzerland
Brunner Praxis für Zahnmedizin
Lucerne, Switzerland
Centrella Zahnärzte
Oberrieden, Switzerland
Bodensee-Implantat-Zentrum AG
Rorschach, Switzerland