Evaluation of the Safety and Performance of the TriOSS®: A Prospective Observational Study in Dental Area

Launched by BIOCERAMED · Feb 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a device called TriOSS®, which is used in dental procedures to help grow new bone in areas like the jaw. The main goal is to gather real-world information about how safe and effective TriOSS® is when used in dental surgeries. This data will help evaluate the device and support its approval under new medical regulations in Europe.

To participate in this study, you need to be an adult over 18 years old who is having specific dental surgeries that require bone augmentation, such as procedures in the sinus or the jawbone. If you join the study, you'll be asked to provide consent for your information to be collected so researchers can monitor the device's performance. However, if you have certain health conditions, like infections or severe bone issues, you may not be eligible. Participating in this trial can help improve dental treatments for future patients, and you can expect to receive care as usual while contributing to valuable research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult males or females (age \> 18 years old);
• • Patients undergoing reconstructive dental surgeries who meet predefined criteria in Instructions For Use (IFU) of TriOSS®;
• • Patients who are able to sign an informed consent form (for data collection);
• • Patients who are candidates for bone augmentation procedures in the sinus or alveolar ridge.
• Exclusion Criteria:
• • Patients who are unable to understand consent and the objectives of the study;
• • Signs of local or systemic acute/ active or chronic infections;
• • Metabolic affections;
• • Severe degenerative diseases, conditions in which general bone grafting is not advisable;
• • Implementation sites that allow product migration;
• • Conditions which require structural support in the skeletal system;
• • Conditions where the implantation site is unstable and not rigidly fixated;
• • Sensibility to the implantable materials;
• • Known hypersensitivity to the implant material.