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

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clinicaltrials.gov/study/NCT04737421
Is a
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Clinical study
0

Clinical Study attributes

NCT Number
NCT047374210
Trial Recruitment Size
1,0000
Trial Sponsor
Nobel Biocare
Nobel Biocare
0
Clinical Trial Start Date
May 26, 2021
0
Primary Completion Date
May 31, 2027
0
Study Completion Date
May 31, 2027
0
Clinical Trial Study Type
Observational0
Intervention Type
Device0
Intervention Name
NobelParallel CC TiUltra implants0
Nobel Biocare N1 TiUltra TCC implants0
NobelActive TiUltra implant0
NobelReplace CC TiUltra implants0
Observational Clinical Trial Type
Other0
Observational Study Perspective
Prospective0
Official Name
A Prospective, Non-interventional, Clinical Study to Evaluate the Safety, Performance and Clinical Benefits of Implants With TiUltra Technology and Associated Prosthetic Components0
Last Updated
September 5, 2021
0
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

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