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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
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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
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Secondary ID [1]
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T-192
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Marginal Bone Level Change
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Condition category
Condition code
Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Marginal bone level change
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Assessment method [1]
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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.
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Timepoint [1]
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Definitive prosthetic delivery to 5-years follow-up
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Secondary outcome [1]
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Marginal bone level change
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Assessment method [1]
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To evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to 1-year and 3-years follow-up visits
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Timepoint [1]
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Definitive Prosthetic delivery to 1-year, Definitive Prosthetic delivery to 3-years
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Secondary outcome [2]
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Cumulative Survival rate/Cumulative success rate
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Assessment method [2]
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To demonstrate cumulative implant survival and success rates from definitive prosthetic placement to 5 years follow-up visit
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Timepoint [2]
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Definitive prosthetic delivery to 5-year follow-up
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Secondary outcome [3]
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Prsothetic suviival and success rate
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Assessment method [3]
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To demonstrate cumulative prosthetic survival and success rates to 5 years follow-up visit
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Timepoint [3]
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Definitive prosthetic delivery to 5-years follow-up
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Secondary outcome [4]
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Sost tissue outcome- Bleeding index
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Assessment method [4]
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To evaluate soft tissue outcome as measured by bleeding index from definitive prosthetic placement to 5 years follow-up visit
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Timepoint [4]
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Definitive prosthetic delivery to 5-years follow-up
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Secondary outcome [5]
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Sost tissue outcome- Plaque index
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Assessment method [5]
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To evaluate soft tissue outcome as measured by plaque index from definitive prosthetic placement to 5 years follow-up visit.
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Timepoint [5]
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Definitive prosthetic delivery to 5-years follow-up
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Secondary outcome [6]
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Sost tissue outcome- Ginigval index
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Assessment method [6]
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To evaluate soft tissue outcome as measured by gingival index from definitive prosthetic placement to 5 years follow-up visit
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Timepoint [6]
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Definitive prosthetic delivery to 5-years follow-up
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Secondary outcome [7]
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Adverse event
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Assessment method [7]
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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.
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Timepoint [7]
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Implant insertion to 5-years follow-up
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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.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/05/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/05/2029
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Actual
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Sample size
Target
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Accrual to date
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Final
1000
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Recruitment in Australia
Recruitment state(s)
NSW,Pert
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Recruitment hospital [1]
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Dentartisans Pty ltd - Pyrmont
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Recruitment hospital [2]
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Bc Prosthodontics - West Perth
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Recruitment hospital [3]
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Melbourne Dental School The University of Melbourne - Melbourne
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Recruitment postcode(s) [1]
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2009 - Pyrmont
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Recruitment postcode(s) [2]
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6005 - West Perth
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Recruitment postcode(s) [3]
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3010 - Melbourne
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Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Illinois
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United States of America
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New York
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United States of America
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Oregon
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Austria
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Vienna
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Austria
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Wien
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Denmark
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Herning
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Finland
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Tampere
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France
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Lyon
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France
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Montpellier
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France
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Paris
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Germany
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Karlstadt
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Italy
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Cattolica
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Italy
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Verona
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Netherlands
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Breda
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Netherlands
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Groningen
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Netherlands
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Hertogenbosch
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Norway
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Harstad
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Portugal
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Lisbon
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Spain
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Barcelona
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Spain
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Málaga
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Spain
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Palma De Mallorca
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Sweden
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Göteborg
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Sweden
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Malmö
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Switzerland
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Egerkingen
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Switzerland
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Luzern
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Switzerland
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Oberrieden
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Switzerland
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Rorschach
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Nobel Biocare
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Address
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/study/NCT04737421
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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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
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