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

NCT06813885 | Active Not Recruiting

• 1 other identifier: TriOSSD01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to collect real-world clinical data to gather information on the performance and safety of the TriOSS® when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence for the device's clinical evaluation, targeting submission to the new Medical Device Regulation (EU) 2017/745.

Conditions

Bone Augmentation

Keywords

prospective observational clinical study; bone substitute; TriOSS ®; real-world clinical data; efficacy and safety; medical device; reconstructive dental surgeries

Outcome Measures

Primary Outcomes (2)

• Primary Performance Endpoint

  Bone consolidation on the surgery site (discrete variable: Yes or No), assessed by X-ray images.

  moment after surgery; 6 months; 12 months; 23 months.

• Safety Endpoint

  The assessment of Adverse Events (AEs) and device deficiencies (DDs) at least possibly related to TriOSS® during the follow-up period of patients.

  moment after surgery; 6 months; 12 months; 23 months.

Secondary Outcomes (2)

• Surgeon's Satisfaction survey on the medical device and Technical Success

  Visit 1 (moment after surgery - baseline and enrolment)

• 2. Quality of life measured through the Oral Health Impact Profile (OHIP-14) Questionnaire

  moment after surgery; 6 months; 12 months; 23 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients undergoing reconstructive dental surgeries.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioceramed: lead
• Egas Moniz - Cooperativa de Ensino Superior, CRL: collaborator

Study Sites (1)

Egas Moniz School of Health and Science

Caparica, Lisbon District, 2825-084, Portugal

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 7, 2025
• Study Start: March 5, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)