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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
Primary Objective: 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.
Secondary Objective:The secondary objectives of this clinical investigation are:
Study design: 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 study devices are divided into four groups:
Subjects will be consecutively included provided they meet all of the inclusion criteria and none of the exclusion criteria. 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 . Possible dropouts and withdrawals, as well as possible serious adverse (device) events, will be carefully monitored during the entire study period
Sequence of treatment: As part of the screening process each subject will undergo a pre-treatment standard of care examination to record demographic characteristics and medical history. The subjects will be informed of the treatment possibilities according to clinic standard of care and about the study. Depending on the clinical indication, clinician preferences and desired esthetic solution the subject will be enrolled into one of the four previously described groups (G1 to G4). Implant surgery-, bone and tissue regenerative- and prosthodontic procedures shall be performed according to IFU and standard of care. Implants may be placed in either healed or extraction sites utilizing one-stage or two-stage surgical protocol with immediate, early or delayed loading to restore single missing tooth, partial or fully edentulous jaws. The treating clinician should decide individually when definitive prosthesis installation is suitable for each subject. Standard of care follow-up visits should be scheduled as close as possible to 1-, 3- and 5- years after definitive prosthetic placement, to ascertain a homogenous data set. Deidentified periapical radiographs from each subject visit shall be uploaded to the study eCRF. All images will be forwarded to the core lab for independent analysis. As part of the screening process each subject will undergo a pre-treatment standard of care examination to record demographic characteristics and medical history. The subjects will be informed of the treatment possibilities according to clinic standard of care and about the study.
Depending on the clinical indication, clinician preferences and desired esthetic solution the subject will be enrolled into one of the four previously described groups (G1 to G4). Implant surgery-, bone and tissue regenerative- and prosthodontic procedures shall be performed according to IFU and standard of care. Implants may be placed in either healed or extraction sites utilizing one-stage or two-stage surgical protocol with immediate, early or delayed loading to restore single missing tooth, partial or fully edentulous jaws. The treating clinician should decide individually when definitive prosthesis installation is suitable for each subject.
Study duration: Once the subject has provided written informed consent and fulfilled all inclusion and none of the exclusion criteria, he/she is considered enrolled. Subject enrolment period is expected to take 7 months from time of initiation at each site. Enrolment in each group will stop once the total group size of 250 subjects has been met. The clinical investigation will continue until each subject has been followed for 5-years after final prosthetic delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal bone level change | To evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to 1-year and 3-years follow-up visits | Definitive Prosthetic delivery to 1-year, Definitive Prosthetic delivery to 3-years |
| Cumulative Survival rate/Cumulative success rate |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madison Prosthodontics | Madison | Alabama | 35758 | United States | ||
| Northwest Oral and Maxillofacial Surgery |
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| 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. |
|
| 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. |
|
| 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. |
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To demonstrate cumulative implant survival and success rates from definitive prosthetic placement to 5 years follow-up visit |
| Definitive prosthetic delivery to 5-year follow-up |
| Prsothetic suviival and success rate | To demonstrate cumulative prosthetic survival and success rates to 5 years follow-up visit | Definitive prosthetic delivery to 5-years follow-up |
| Sost tissue outcome- Bleeding index | To evaluate soft tissue outcome as measured by bleeding index from definitive prosthetic placement to 5 years follow-up visit | Definitive prosthetic delivery to 5-years follow-up |
| Sost tissue outcome- Plaque index | To evaluate soft tissue outcome as measured by plaque index from definitive prosthetic placement to 5 years follow-up visit. | Definitive prosthetic delivery to 5-years follow-up |
| Sost tissue outcome- Ginigval index | To evaluate soft tissue outcome as measured by gingival index from definitive prosthetic placement to 5 years follow-up visit | Definitive prosthetic delivery to 5-years follow-up |
| Adverse event | To evaluate Serious Adverse Device Effects , Unanticipated Serious Adverse Device Effect , Adverse Device Effects and Device Deficiency from implant insertion until 5 years follow-up visit. | Implant insertion to 5-years follow-up |
| Arlington Heights |
| Illinois |
| 60005 |
| United States |
| Midwest Dental Implantology | Saint Charles | Illinois | 60174 | United States |
| New York Center for Orthognathic and Maxillofacial Surgery | New York | New York | 10022 | United States |
| Periodontal Associates | Tualatin | Oregon | 97062 | United States |
| Dentartisans Pty ltd | Pyrmont | New South Wales | 2009 | Australia |
| Bc Prosthodontics | West Perth | Perth | 6005 | Australia |
| Melbourne Dental School The University of Melbourne | Melbourne | 3010 | Australia |
| Akademie für orale Implantologie GmbH & Co | Vienna | 1090 | Austria |
| Implantologie und Ästhetische Zahnheilkunde | Vienna | 1190 | Austria |
| Herning Implantat Center | Herning | Herning | 7400 | Denmark |
| Dental Center Helmiäinen | Tampere | 33200 | Finland |
| Cabinet du Dr Noharet | Lyon | 69002 | France |
| BGLP | Montpellier | 34090 | France |
| IFCIA | Paris | 75017 | France |
| DrS - Schöne Zähne - Dr. Scherg Praxis für Implantologie & Ästhetik | Karlstadt am Main | 97753 | Germany |
| Studio Odontoiatrico Specialistico Ban Mancini Fabbri | Cattolica | 47841 | Italy |
| UOC di Chirurgia Maxillo-Facciale e Odontoiatria | Verona | 37134 | Italy |
| Staas & Bergmans Zorgvooruwmond B.V. | 's-Hertogenbosch | 5216 | Netherlands |
| ParoBrea- Parodontologie & Implantologie | Breda | 4819 | Netherlands |
| Department of Oral and Maxillofacial Surgery University Medical Center Groningen | Groningen | 9713 | Netherlands |
| The Oris Dental Harstad | Harstad | 9405 | Norway |
| Maló Clinic | Lisbon | 1600-042 | Portugal |
| Clinica Lluch | Barcelona | 08006 | Spain |
| Clinica Dental Crooke & Laguna | Málaga | 29016 | Spain |
| Altés & Mesquida | Palma de Mallorca | 07004 | Spain |
| Folktandvården Västra Götaland, Brånemarkkliniken | Gothenburg | 413 90 | Sweden |
| Pequrio AB | Malmö | 217 72 | Sweden |
| Dentalspecialist | Egerkingen | 4622 | Switzerland |
| Brunner Praxis für Zahnmedizin | Lucerne | 6003 | Switzerland |
| Centrella Zahnärzte | Oberrieden | 8942 | Switzerland |
| Bodensee-Implantat-Zentrum AG | Rorschach | 9400 | Switzerland |