A Clinical Study on Implants With TiUltra Technology and Associated Prosthetic Components

Running, not enrolling

Conditions studied: Marginal Bone Level Change

In brief

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

Key facts

Study ID

NCT04737421

Run by

Nobel Biocare

People needed

1000

Starts

2021-05-26

Expected to finish

2029-05-31

Last updated by the study team

2025-05-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject signed the informed consent
• Subject is between 18 and 70 years of age
• Subjects presented with the need of single, multiple or full arch implant rehabilitation in any region of the mouth.
• Subject with medical and anatomical conditions that are in accordance with the applicable instructions for use (IFU).
• Subject with sufficient bone volume for implant placement.
• Subject is compliant with good oral hygiene as judged by the clinician.

You may not qualify if…

• Anatomical conditions discovered during surgery preventing the use of intended implant system.
• Subjects with history of allergy or adverse reactions to any materials used
• Uncontrolled diabetes (subjects with history of diabetes mismanagement and/or known A1c level above 8%)*
• Heavy smokers (>10 cigarettes per day)
• Severe bruxism or dysfunctional tendencies
• Previous oro-maxillo facial radiotheraphy
• Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc)
• Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous radiation.
• Acute, untreated periodontitis in the planned implantation site or adjacent tissue.
• Infections in the planned implantation site or adjacent tissue.
• Documented complete remission of >3 years if history of non-oral cancer.
• Pregnant or lactating women at the time of implant insertion. *Assessment of A1C level is not required unless it is standard of care at the treating clinic

Where it is running

• 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

Full record on ClinicalTrials.gov

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