A new clinical study has been announced focusing on the NobelZygoma™ TiUltra™ Implant System, aiming to address critical conditions like edentulous maxilla, maxillary bone loss, and atrophic maxilla. The trial, not yet recruiting, is sponsored by Nobel Biocare and evaluates the performance and safety of advanced implant devices designed for challenging maxillary conditions.
Dental professionals, clinical researchers, and regulatory teams involved in medical device supervision should track this study closely as it unfolds. Below, we provide an in-depth review of the trial details, including its purpose, significance, and the devices under investigation.
In this article:
- What is the focus of this study?
- Which devices are being studied?
- Who is sponsoring the trial and what is its current status?
- Frequently Asked Questions
- Conclusion
- Disclaimer
- Full Announcement
What is the focus of this study?
The study aims to assess the efficacy and safety of advanced implant solutions for severely compromised upper jaw conditions. Specifically, it targets individuals with atrophic maxilla, edentulous maxilla, and severe maxillary bone loss, providing a valuable resource for improving long-term patient outcomes. The inclusion of advanced zygomatic implants in the trial highlights efforts to tackle limitations faced by conventional implants in these cases.
Which devices are being studied?
The NobelZygoma™ TiUltra™ Implant System integrates innovative components to provide enhanced performance and reliability. The study will evaluate the following core devices:
- NobelZygoma™ 0° CC TiUltra™ Implant: Designed for optimized placement in zygomatic and maxillary bones.
- NobelZygoma™ 45° Ext Hex TiUltra™ Implant: Engineered for angled placements, a key solution for patients with severe bone loss.
- Multi-Unit Abutment Xeal Zygoma Ext Hex RP: An important interface designed to ensure adaptability for prosthetic attachment.
- Other components include 17°, 45°, and 60° Multi-Unit Abutments with CC and Xeal technologies.
Collectively, these devices are designed to support both surgical outcomes and long-term patient rehabilitation in demanding clinical cases.
Who is sponsoring the trial and what is its current status?
This multi-faceted investigation is sponsored by Nobel Biocare, a leader in dental restoration systems and implantology. While the study is not yet recruiting, further updates are expected as preparations finalize. Contributions from leading clinicians and researchers will be pivotal in ensuring compliance with regulatory and safety standards throughout the trial.
Why this matters for professionals
The trial’s findings could significantly influence treatment protocols for individuals with severe maxillofacial conditions. Professionals in the clinical, quality, and regulatory sectors should monitor this trial closely to align with evolving evidence and technological advances.
Frequently Asked Questions
- What conditions does this trial address?
The study targets atrophic maxilla, edentulous maxilla, and maxillary bone loss. - Are participants currently being recruited?
No, the study is not yet recruiting but is expected to open enrollment soon. - Who is the study’s sponsor?
Nobel Biocare, a prominent manufacturer of implant systems.
Conclusion
The NobelZygoma™ TiUltra™ Implant System trial represents a pivotal step in advancing treatments for severe maxillary conditions. With the potential to improve long-term clinical outcomes, this study is of particular interest to professionals managing medical device compliance, clinical trials, or restorative dentistry solutions. Stay informed on this innovative initiative as it progresses.
Disclaimer
This article is provided for informational purposes only. It is not intended as legal or clinical advice. Professionals should consult relevant guidelines for decision-making.
Full Announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07258940?term=medical+device