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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04737421




Registration number
NCT04737421
Ethics application status
Date submitted
28/01/2021
Date registered
3/02/2021
Date last updated
25/05/2025

Titles & IDs
Public title
A Clinical Study on Implants With TiUltra Technology and Associated Prosthetic Components
Scientific title
A Prospective, Non-interventional, Clinical Study to Evaluate the Safety, Performance and Clinical Benefits of Implants With TiUltra Technology and Associated Prosthetic Components
Secondary ID [1] 0 0
T-192
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Marginal Bone Level Change 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - NobelActive TiUltra implant
Treatment: Devices - NobelParallel CC TiUltra implants
Treatment: Devices - NobelReplace CC TiUltra implants
Treatment: Devices - Nobel Biocare N1 TiUltra TCC implants

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.

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.

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.

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.


Treatment: Devices: 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.

Treatment: Devices: 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.

Treatment: Devices: 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.

Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Marginal bone level change
Timepoint [1] 0 0
Definitive prosthetic delivery to 5-years follow-up
Secondary outcome [1] 0 0
Marginal bone level change
Timepoint [1] 0 0
Definitive Prosthetic delivery to 1-year, Definitive Prosthetic delivery to 3-years
Secondary outcome [2] 0 0
Cumulative Survival rate/Cumulative success rate
Timepoint [2] 0 0
Definitive prosthetic delivery to 5-year follow-up
Secondary outcome [3] 0 0
Prsothetic suviival and success rate
Timepoint [3] 0 0
Definitive prosthetic delivery to 5-years follow-up
Secondary outcome [4] 0 0
Sost tissue outcome- Bleeding index
Timepoint [4] 0 0
Definitive prosthetic delivery to 5-years follow-up
Secondary outcome [5] 0 0
Sost tissue outcome- Plaque index
Timepoint [5] 0 0
Definitive prosthetic delivery to 5-years follow-up
Secondary outcome [6] 0 0
Sost tissue outcome- Ginigval index
Timepoint [6] 0 0
Definitive prosthetic delivery to 5-years follow-up
Secondary outcome [7] 0 0
Adverse event
Timepoint [7] 0 0
Implant insertion to 5-years follow-up

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2029
Actual
Sample size
Target
Accrual to date
Final
1000
Recruitment in Australia
Recruitment state(s)
NSW,Pert
Recruitment hospital [1] 0 0
Dentartisans Pty ltd - Pyrmont
Recruitment hospital [2] 0 0
Bc Prosthodontics - West Perth
Recruitment hospital [3] 0 0
Melbourne Dental School The University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
2009 - Pyrmont
Recruitment postcode(s) [2] 0 0
6005 - West Perth
Recruitment postcode(s) [3] 0 0
3010 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
Austria
State/province [5] 0 0
Vienna
Country [6] 0 0
Austria
State/province [6] 0 0
Wien
Country [7] 0 0
Denmark
State/province [7] 0 0
Herning
Country [8] 0 0
Finland
State/province [8] 0 0
Tampere
Country [9] 0 0
France
State/province [9] 0 0
Lyon
Country [10] 0 0
France
State/province [10] 0 0
Montpellier
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
Germany
State/province [12] 0 0
Karlstadt
Country [13] 0 0
Italy
State/province [13] 0 0
Cattolica
Country [14] 0 0
Italy
State/province [14] 0 0
Verona
Country [15] 0 0
Netherlands
State/province [15] 0 0
Breda
Country [16] 0 0
Netherlands
State/province [16] 0 0
Groningen
Country [17] 0 0
Netherlands
State/province [17] 0 0
Hertogenbosch
Country [18] 0 0
Norway
State/province [18] 0 0
Harstad
Country [19] 0 0
Portugal
State/province [19] 0 0
Lisbon
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Spain
State/province [21] 0 0
Málaga
Country [22] 0 0
Spain
State/province [22] 0 0
Palma De Mallorca
Country [23] 0 0
Sweden
State/province [23] 0 0
Göteborg
Country [24] 0 0
Sweden
State/province [24] 0 0
Malmö
Country [25] 0 0
Switzerland
State/province [25] 0 0
Egerkingen
Country [26] 0 0
Switzerland
State/province [26] 0 0
Luzern
Country [27] 0 0
Switzerland
State/province [27] 0 0
Oberrieden
Country [28] 0 0
Switzerland
State/province [28] 0 0
Rorschach

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nobel Biocare
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04737421