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

NCT04737421 | Active Not Recruiting

• 1 other identifier: T-192
• Study Type: observational
• Target: 1,000
• Locations: 13 countries
• Sites: 30

Brief 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

Conditions

Marginal Bone Level Change

Keywords

bone remodelling

Outcome Measures

Primary Outcomes (1)

• Marginal bone level change

  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.

  Definitive prosthetic delivery to 5-years follow-up

Secondary Outcomes (7)

• Marginal bone level change

  Definitive Prosthetic delivery to 1-year, Definitive Prosthetic delivery to 3-years

• Cumulative Survival rate/Cumulative success rate

  Definitive prosthetic delivery to 5-year follow-up

• Prsothetic suviival and success rate

  Definitive prosthetic delivery to 5-years follow-up

• Sost tissue outcome- Bleeding index

  Definitive prosthetic delivery to 5-years follow-up

• Sost tissue outcome- Plaque index

  Definitive prosthetic delivery to 5-years follow-up

Study Arms (4)

Group 1 (G1): NobelActive TiUltra implants (3.0, NP, RP, WP)

Subjects will be enrolled into Group 1 and treated with NobelActive TiUltra implants, only if it is driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic.

Device: NobelActive TiUltra implant

Group 2 (G2): NobelParallel CC TiUltra implants (NP, RP; WP)

Subjects will be enrolled into Group 1 and treated with NobelParallel CC TiUltra implants, only if it is driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic.

Device: NobelParallel CC TiUltra implants

Group 3 (G3): NobelReplace CC TiUltra implants (NP, RP)

Subjects will be enrolled into Group 1 and treated with NobelReplace CC TiUltra implants, only if it is driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic.

Device: NobelReplace CC TiUltra implants

Group 4 (G4): Nobel Biocare N1 TiUltra TCC implants (NP, RP)

Subjects will be enrolled into Group 1 and treated with Nobel Biocare N1 TiUltra TCC implants , only if it is driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic.

Device: Nobel Biocare N1 TiUltra TCC implants

Interventions

NobelActive TiUltra implant DEVICE

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.

Group 1 (G1): NobelActive TiUltra implants (3.0, NP, RP, WP)

NobelParallel CC TiUltra implants DEVICE

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.

Group 2 (G2): NobelParallel CC TiUltra implants (NP, RP; WP)

NobelReplace CC TiUltra implants DEVICE

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.

Group 3 (G3): NobelReplace CC TiUltra implants (NP, RP)

Nobel Biocare N1 TiUltra TCC implants DEVICE

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.

Group 4 (G4): Nobel Biocare N1 TiUltra TCC implants (NP, RP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be consecutively included provided they meet all of the inclusion criteria and none of the exclusion criteria.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. If the subject wishes to withdraw from the clinical study, he/she may do so at any time and for any reason during the clinical study. If provided, the reason for withdrawal should be recorded and documented in the subject's medical record and in the eCRF.

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

Sponsors & Collaborators

• Nobel Biocare: lead

Study Sites (32)

Madison Prosthodontics

Madison, Alabama, 35758, United States

Location

Northwest Oral and Maxillofacial Surgery

Arlington Heights, Illinois, 60005, United States

Location

Midwest Dental Implantology

Saint Charles, Illinois, 60174, United States

Location

New York Center for Orthognathic and Maxillofacial Surgery

New York, New York, 10022, United States

Location

Periodontal Associates

Tualatin, Oregon, 97062, United States

Location

Dentartisans Pty ltd

Pyrmont, New South Wales, 2009, Australia

Location

Bc Prosthodontics

West Perth, Perth, 6005, Australia

Location

Melbourne Dental School The University of Melbourne

Melbourne, 3010, Australia

Location

Akademie für orale Implantologie GmbH & Co

Vienna, 1090, Austria

Location

Implantologie und Ästhetische Zahnheilkunde

Vienna, 1190, Austria

Location

Herning Implantat Center

Herning, Herning, 7400, Denmark

Location

Dental Center Helmiäinen

Tampere, 33200, Finland

Location

Cabinet du Dr Noharet

Lyon, 69002, France

Location

BGLP

Montpellier, 34090, France

Location

IFCIA

Paris, 75017, France

Location

DrS - Schöne Zähne - Dr. Scherg Praxis für Implantologie & Ästhetik

Karlstadt am Main, 97753, Germany

Location

Studio Odontoiatrico Specialistico Ban Mancini Fabbri

Cattolica, 47841, Italy

Location

UOC di Chirurgia Maxillo-Facciale e Odontoiatria

Verona, 37134, Italy

Location

Staas & Bergmans Zorgvooruwmond B.V.

's-Hertogenbosch, 5216, Netherlands

Location

ParoBrea- Parodontologie & Implantologie

Breda, 4819, Netherlands

Location

Department of Oral and Maxillofacial Surgery University Medical Center Groningen

Groningen, 9713, Netherlands

Location

The Oris Dental Harstad

Harstad, 9405, Norway

Location

Maló Clinic

Lisbon, 1600-042, Portugal

Location

Clinica Lluch

Barcelona, 08006, Spain

Location

Clinica Dental Crooke & Laguna

Málaga, 29016, Spain

Location

Altés & Mesquida

Palma de Mallorca, 07004, Spain

Location

Folktandvården Västra Götaland, Brånemarkkliniken

Gothenburg, 413 90, Sweden

Location

Pequrio AB

Malmo, 217 72, Sweden

Location

Dentalspecialist

Egerkingen, 4622, Switzerland

Location

Brunner Praxis für Zahnmedizin

Lucerne, 6003, Switzerland

Location

Centrella Zahnärzte

Oberrieden, 8942, Switzerland

Location

Bodensee-Implantat-Zentrum AG

Rorschach, 9400, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 3, 2021
• Study Start: May 26, 2021
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1); DK (1); FR (3); US (5); AU (3); DE (1); IT (2); FI (1); NL (3); NO (1); ES (3); SE (2); CH (4)