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Clinical Trials in Italy / NCT04737421
Active, not recruiting Observational

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

NCT04737421 · tracked via the Priya Life Science Italy tracker
Sponsor
Nobel Biocare
Phase
Observational
Started
2021-05-26
Last updated
2025-05-25

Condition(s) studied

Marginal Bone Level Change

Investigational drug(s) / intervention(s)

NobelActive TiUltra implantNobelParallel CC TiUltra implantsNobelReplace CC TiUltra implantsNobel Biocare N1 TiUltra TCC implants

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.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Primary outcome measure(s)

  • Marginal bone level change — Definitive prosthetic delivery to 5-years follow-up
    The primary endpoint is to evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to the 5-year follow-up visit.

Trial sites (32)

FacilityCityRegionStatus
Madison Prosthodontics Madison Alabama
Northwest Oral and Maxillofacial Surgery Arlington Heights Illinois
Midwest Dental Implantology Saint Charles Illinois
New York Center for Orthognathic and Maxillofacial Surgery New York New York
Periodontal Associates Tualatin Oregon
Dentartisans Pty ltd Pyrmont New South Wales
Bc Prosthodontics West Perth Perth
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
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 Malmö Sweden
Dentalspecialist Egerkingen Switzerland
Brunner Praxis für Zahnmedizin Lucerne Switzerland
Centrella Zahnärzte Oberrieden Switzerland
Bodensee-Implantat-Zentrum AG Rorschach Switzerland

More Nobel Biocare trials in Italy

NobelZygoma TiUltra Implant System Study Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04737421 on ClinicalTrials.gov ↗ ← All trials in Italy