This study aims to collect real-world clinical data to gather information on the performance and safety of the Neobone® 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.
Neobone® is a synthetic and resorbable implantable synthetic calcium phosphate ceramic bone substitute, composed of hydroxyapatite and beta-tricalcium phosphate. The structures composed of these calcium phosphate ceramic structures 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 biphasic composition enhances the ceramic resorption, allowing a resorption rate compatible with the physiology of bone cells. Neobone® is a single use, gamma radiation sterilized medical device. Neobone® is a single use, gamma sterilized, implantable biodegradable medical device intended to be used in filling bony voids or gaps within the skeletal system that do not contribute to the structural stability of the bone, and 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. Neobone® 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. Neobone® is a class III medical device and is intended for long-term use and will be placed in contact with cancellous tissue and adjacent tissues through surgically invasive techniques. 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 Neobone® 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 phase.. 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 Neobone® 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).
Study Type
OBSERVATIONAL
Enrollment
66
Egas Moniz School of Health and Science Caparica
Lisbon, Portugal
RECRUITINGClinical and radiographic performance endpoint:
\- Bone gain (augmentation volume in mm³) at 6 months, assessed by computed tomography (CBCT);
Time frame: 6 months
Safety Endpoint
The assessment of adverse events (AE) and device deficiencies (DD) during the patient follow-up period relation to the medical device. This endpoint will be evaluated at each follow-up visit.
Time frame: 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).
Clinical and radiographic performance endpoint:
\- Bone regeneration at the surgical site, clinically viable for implant placement at 6 months (Yes/No), defined as sufficient bone volume and quality, based on clinical evaluation and CBCT, allowing safe implant placement;
Time frame: 6 months
Technical success rate
Technical success rate and surgeon's satisfaction with the medical device, assessed through a post-surgical questionnaire evaluating usability and overall performance.
Time frame: moment after surgery
Quality of life assessment
Quality of life will be assessed using the Oral Health Impact Profile (OHIP-14) questionnaire, administered at baseline, immediately post-surgery, and within the first 7 days postoperatively and during follow-up visits at 6, 12, and 23 months.
Time frame: 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).
Radiographic bone density assessment
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Radiographic bone density (Hounsfield units) at 6 months, assessed by CBCT in the regenerated area. The grayscale values (or relative density measurements) will be used to estimate the degree of bone mineralization in the treated site. Elevated radiographic bone density values indicate good mineralization and quality of the regenerated bone. These data serve as complementary indicators of the quality of the bone tissue obtained with the use of the synthetic bone substitute.
Time frame: 6 months
Pain level assessment
Pain level will be reported using the Visual Analogue Scale (VAS, 0-10), assessed at baseline, immediately post-surgery, within the first 7 days post-operatively, and during follow-up visits at 6, 12, and 23 months.
Time frame: 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).
Bone volume variation (in %) assessment
Bone volume variation (in %) assessed using scans taken at baseline and at 6 months. Volumetric analysis will be performed by superimposing two CBCT images, with the system automatically calculating the percentage difference. This allows quantification of bone gain or maintenance over time. Positive values indicate bone gain, zero indicates maintenance of bone volume, and negative values indicate bone loss. A greater positive volume variation indicates more effective bone regeneration, reflecting a successful outcome at the treated site.
Time frame: 6 months