A Clinical Study on Implants With TiUltra Technology and Associated Prosthetic Components
Public ClinicalTrials.gov record NCT04737421. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Non-interventional, Clinical Study to Evaluate the Safety, Performance and Clinical Benefits of Implants With TiUltra Technology and Associated Prosthetic Components
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04737421
- Recruitment status
- Active, not recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,000 participants
Conditions and interventions
Conditions
Interventions
- NobelActive TiUltra implant Device
- NobelParallel CC TiUltra implants Device
- NobelReplace CC TiUltra implants Device
- Nobel Biocare N1 TiUltra TCC implants Device
Device
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 25, 2021
- Primary completion
- May 30, 2029
- Completion
- May 30, 2029
- Last update posted
- May 24, 2025
2021 – 2029
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Madison Prosthodontics | Madison | Alabama | 35758 | — |
| Northwest Oral and Maxillofacial Surgery | Arlington Heights | Illinois | 60005 | — |
| Midwest Dental Implantology | Saint Charles | Illinois | 60174 | — |
| New York Center for Orthognathic and Maxillofacial Surgery | New York | New York | 10022 | — |
| Periodontal Associates | Tualatin | Oregon | 97062 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04737421, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 24, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04737421 live on ClinicalTrials.gov.