Evaluating the safety and performance of TriOSS® in dental procedures
Evaluation of the Safety and Performance of the TriOSS®: a Prospective Observational Study in Dental Area
This study is testing how safe and effective the TriOSS® bone substitute is for adults getting dental surgeries that need bone augmentation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bioceramed Industry-sponsored |
| Locations | 1 site (Caparica, Lisboa) |
| Trial ID | NCT06813885 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world clinical data on the safety and performance of the TriOSS®, a synthetic calcium phosphate ceramic bone substitute, used in dental bone augmentation procedures. The study will collect information from adult patients undergoing reconstructive dental surgeries, focusing on the device's effectiveness and safety when used as intended. The results will contribute to clinical evidence for regulatory submission under the new Medical Device Regulation in the EU. The study does not involve additional risks or direct benefits for participants, as it observes standard practice procedures.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are undergoing reconstructive dental surgeries and are suitable for bone augmentation procedures.
Not a fit: Patients with acute infections, severe degenerative diseases, or conditions requiring structural support in the skeletal system may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of TriOSS® for bone augmentation, potentially improving patient outcomes in dental surgeries.
How similar studies have performed: While this study is observational and focuses on a specific device, similar studies evaluating bone substitutes have shown promising results in enhancing bone regeneration.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Caparica, Lisboa
- Egas Moniz School of Health and Science — Caparica, Lisboa, Portugal (Recruiting)
Study contacts
- Study coordinator: Alexandre Barros
- Email: abarros@bioceramed.com
- Phone: (+351) 253 573 460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.