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

NCT04737421 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-05-25

No results posted yet for this 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

Conditions

  • Marginal Bone Level Change

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Nobel Biocare

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2029-05-31
Completion
2029-05-31

Countries

  • United States
  • Australia
  • Austria
  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • Sweden
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04737421 on ClinicalTrials.gov