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

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

NCT Number	NCT04737421
Lead Sponsor	Nobel Biocare
Conditions	Marginal Bone Level Change
Enrollment	1,000 participants
Start Date	2021-05-26
Primary Completion	2029-05-31 (estimated)
Study Completion	2029-05-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-25