Evaluation of the Safety and Performance of the Neocement® Inject P: A Prospective Observational Study in Dental Area (NeoInjDent01)

Bioceramed

Status: Enrolling

Conditions: Bone Augmentation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07179510

NeoInjDent01

Details and patient eligibility

About

This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® Inject P 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.

Full description

Neocement® Inject P is a synthetic bone substitute composed of calcium phosphates (tetracalcium phosphate and beta-tricalcium phosphate). It consists of two parts: a solid phase and an aqueous solution. The solid phase is composed of calcium phosphates (tetracalcium phosphate and beta-tricalcium phosphate) and chitosan (from animal origin), and the aqueous solution is composed of citric acid and glucose. The solid phase is delivered in a P-system (patented system) and the aqueous solution is delivered in a flask. Neocement® Inject P is a single use, biodegradable, gamma radiation sterilized medical device. Neocement® Inject P´s final composition is designed to improve bone quality and accelerate bone regeneration in cases of fractures or bone loss.

Neocement® Inject P is a single use, gamma sterilized, implantable biodegradable medical device. It is intended for the purpose of filling bony voids or gaps within the skeletal system that do not contribute to the structural stability of the bone. Additionally, it is utilized in reconstructive dental and maxillofacial surgeries. These defects may arise from surgical procedures or result from osseous damage due to traumatic injury to the bone.

Neocement® Inject P is intended to be used in operating rooms by trained orthopaedic surgeons, as well as in dental offices or operating rooms by dentists and maxillofacial surgeons who have medical and technical knowledge in bone grafting.

Neocement® Inject P is a classe III medical device and is intended for long-term application and will be placed in contact with cancellous tissue and adjacent tissues by surgically invasive techniques.

This advanced biomaterial offers a reliable solution for addressing bone fractures and loss, demonstrating significant potential in enhancing patient outcomes through accelerated and durable bone regeneration.

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.

Participation in the study may provide a better understanding of treatment with Neocement® Inject P and potentially influence future clinical decisions, contributing to the continuous improvement of healthcare.

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 medical.

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 clinical evidence on the device's performance and safety in the post-market. This complements the data collected during the pre-market phases, thus protecting patient safety. 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 - Medical Device Regulation No. 2017/745. This approach is crucial to achieving the objectives set, guaranteeing the safety and efficacy of the devices in circulation. The clinical study population consists of adult patients (aged > 18 years old) who undergo reconstructive dental surgery using the Neocement® Inject P medical device. Patients will be followed as per local standard medical practices of the centre for 2 years. Clinical data will be collected at 6 points in time: Visit 1 (before surgery - baseline and enrolment), Visit 2 (moment after surgery), Visit 3 (7 ± 1 days), Visit 4 (6 months ±3 weeks), Visit 5 (12 months ±30 days) and Visit 6 (23 months ±30 days).

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult males or females (age > 18 years old);
• Patients who are able to sign an informed consent form (for data collection);
• Patients undergoing reconstructive dental surgery and indicated for the use of Neocement® Inject P;

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.