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

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Primary and study completion dates: May 31, 2027 to May 31, 2029
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 1 to 32
    • Eligibility criteria revised
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 1, 2021 to May 26, 2021
    v3
  3. Study title shortened, about 2 wordsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT04737421
Lead Sponsor Nobel Biocare
Conditions
(from sponsor)		 Marginal Bone Level Change
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov