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.
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;
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;
The clinical study population consists of adult patients (aged \> 18 years old) who undergo reconstructive dental surgery using the Neocement® Inject P medical device.
Cohort
Prospective
Not listed
Clinical and radiographic performance endpoint:
\- Bone gain (augmentation volume in mm³) at 6 months, assessed by computed tomography (CBCT);
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;
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.
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.
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.
Radiographic bone density assessment
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.
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.
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Bioceramed
Lead sponsor
Egas Moniz - Cooperativa de Ensino Superior, CRL
Collaborator
