Clinical trial NCT06813885: Evaluation of the Safety and Performance of the TriOSS®: A Prospective Observational Study in Dental Area
Official title: Evaluation of the Safety and Performance of the TriOSS®: A Prospective Observational Study in Dental Area
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bone Augmentation
Keywords: prospective observational clinical study
bone substitute
TriOSS ®
real-world clinical data
efficacy and safety
medical device
reconstructive dental surgeries
Lead sponsor: Bioceramed
Sponsor class: INDUSTRY
Collaborators: name: Egas Moniz - Cooperativa de Ensino Superior, CRL
First posted: 2025-02-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of adult patients undergoing reconstructive dental surgeries.

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.

Detailed description: TriOSS® is an implantable synthetic calcium phosphate ceramic bone substitute, composed of beta-tricalcium phosphate. The structures composed of this calcium phosphate ceramic material are rapidly osseointegrated due to its chemical composition, which is similar to the mineral phase of the human bone, and due to the interconnected porosity allowing a total vascularization of the implant. Since beta-tricalcium phosphate is more soluble than hydroxyapatite, this material composition enhances and accelerates the bone regeneration process in case of fracture or bone loss. TriOSS® is constituted by the following components: β-tricalcium phosphate, apyrogenic water, dispersing agent, polyurethane foam, and polyvinyl pyrrolidone but most of them don't have a direct contact with the patient.

TriOSS® is gamma sterilized, implantable medical device intended to be use in filling bony voids or gaps of the skeletal system (such as the sinus and alveolar ridge) that are not intrinsic to the stability of the bony structure. These defects may be surgically created defects or osseous defects created from traumatic injury to the bone in adults.

TriOSS® holds CE marking since 2016 and according to rule 8 of Annex VIII of the European Regulation n°2017/745, this product is a class III medical device.

This observational post-market study will collect data relating to standard practice procedures, therefore there are no additional risks or direct benefits associated with participating in this registry for the patient.

This study based on observations of clinical practice aims to collect clinical data to keep up to date the information on the performance and safety of the medical device when used in accordance with its intended use and current clinical applications. The results of the clinical study shall be used as clinical evidence for clinical evaluation of the device aiming submission to the new Medical Device Regulation (EU) 2017/745.

The post-market study is meant to identify and analyse emerging risks, ensure the continued acceptability of the benefit/risk ratio and also identify possible systematic misuse or unauthorized use of the medical device. This protocol does not include any planned new uses, new populations, new materials or design changes.

The results from the prospective observational post-market study will provide an evidence base for assessing the device's performance and safety after its market launch. Detecting real discrepancies in clinical performance between of the medical device early on can offer valuable opportunities to improve device design. This complements the data collected during the pre-market phases, thus improving patient selection. Active surveillance of the safety of medical devices, achieved through the continuous monitoring of vast sources of clinical data, is a priority in the field of medical devices, a requirement of MDR regulation No. 2017/745. This approach is crucial to achieving the objectives set, guaranteeing the safety and efficacy of the devices in circulation.

Patients will be followed as per local standard medical practices of the centre for 2 years.

Clinical data will be collected at 4 points in time: Visit 1 (moment after surgery - baseline and enrolment), Visit 2 (6 months ±3 weeks), Visit 3 (12 months ±30 days) and Visit 4 (23 months ±30 days).

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.

Primary outcomes:
measure: Primary Performance Endpoint
timeFrame: moment after surgery; 6 months; 12 months; 23 months.
measure: Safety Endpoint
timeFrame: moment after surgery; 6 months; 12 months; 23 months.
Secondary outcomes:
measure: Surgeon's Satisfaction survey on the medical device and Technical Success
timeFrame: Visit 1 (moment after surgery - baseline and enrolment)
measure: 2. Quality of life measured through the Oral Health Impact Profile (OHIP-14) Questionnaire
timeFrame: moment after surgery; 6 months; 12 months; 23 months.
Other outcomes:
Locations:
city: Caparica
country: Portugal
facility: Egas Moniz School of Health and Science
state: Lisboa
Study officials:
References: