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

Launched by NOBEL BIOCARE · Feb 2, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new type of dental implant called TiUltra, which is designed for patients who need single, multiple, or full arch restorations in their mouths. The main goal is to see if these new implants perform as well as a previously used type, called NobelActive TiUnite, by measuring changes in bone levels around the implants over five years. The study will involve about 1,000 participants across up to 30 locations, and each participant will be assigned to a group based on their specific dental needs.

To join this trial, participants should be between 18 and 65 years old, have enough bone for the implants, and need dental implants in their mouth. They must also be committed to maintaining good oral hygiene. Participants can expect to receive their implants and will be followed for five years to monitor their progress. It's important to note that individuals with certain medical conditions, like uncontrolled diabetes or severe gum disease, may not be eligible. This trial is currently recruiting, so interested individuals should discuss it with their dentist to see if they qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject signed the informed consent
• • Subject is between 18 and 70 years of age
• • Subjects presented with the need of single, multiple or full arch implant rehabilitation in any region of the mouth.
• • Subject with medical and anatomical conditions that are in accordance with the applicable instructions for use (IFU).
• • Subject with sufficient bone volume for implant placement.
• • Subject is compliant with good oral hygiene as judged by the clinician.
• Exclusion Criteria:
• • Anatomical conditions discovered during surgery preventing the use of intended implant system.
• • Subjects with history of allergy or adverse reactions to any materials used
• • Uncontrolled diabetes (subjects with history of diabetes mismanagement and/or known A1c level above 8%)\*
• • Heavy smokers (\>10 cigarettes per day)
• • Severe bruxism or dysfunctional tendencies
• • Previous oro-maxillo facial radiotheraphy
• • Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc)
• • Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous radiation.
• • Acute, untreated periodontitis in the planned implantation site or adjacent tissue.
• • Infections in the planned implantation site or adjacent tissue.
• • Documented complete remission of \>3 years if history of non-oral cancer.
• • Pregnant or lactating women at the time of implant insertion. \*Assessment of A1C level is not required unless it is standard of care at the treating clinic