Pilot Clinical Study on the Efficacy of a Flexible Hydroxyapatite-Based Composite for the Regeneration of Jaw Bone Defects

Following a review of the scientific literature, it was found that there are no clinical studies but only in vitro and in vivo studies, which show promising results in terms of bone formation and integration. However, it is necessary to evaluate how well the regenerated bone maintains its structural integrity over time, considering masticatory function and biomechanics in real-life scenarios. Factors such as mechanical load, remodeling dynamics, and interactions with surrounding tissues could influence the long-term stability of the regenerated bone. Additionally, another important aspect to study is the potential complications and adverse effects associated with the use of the flexible HAp-based composite.

Study Objectives The primary objective is to evaluate the efficacy in terms of regenerated bone volume using the new flexible HAp-based composite in mixed bone defects of the jawbones.

Primary Outcome Measures The volume of regenerated bone will be measured using CBCT scans before device placement, immediately after the surgical procedure, and at 8 months post-procedure. The percentage of regenerated bone obtained compared to the initially planned augmentation, i.e., the mean volume difference, will be calculated before the surgical procedure, immediately after device placement, and at 8 months.

Secondary Objectives These include evaluating intraoperative and postoperative complications occurring at the time of placement or after device placement, assessing the conditions of peri-implant hard and soft tissues, measuring overall patient satisfaction with the treatment, analyzing the correlation between implant survival and various systemic and clinical patient factors, and conducting a histological evaluation of vascularization and new bone formation in samples of regenerated bone taken during implant site preparation.

Secondary Outcome Measures The condition of hard tissues will be assessed based on periapical intraoral radiographs. For soft tissue conditions, for each implant site, peri-implant probing depth (PPD), bleeding on probing (BOP), presence of peri-implant plaque (mPLI), and the amount of keratinized gingiva will be considered at m3, m6, m9, and m12 from implant placement. Any pathological events such as neurological lesions, exposures, infections, inflammation, fractures, or loosening of prosthetic screws, and prosthesis fractures reported in the clinical record during or after device placement and throughout the clinical follow-up will be evaluated as outcomes of intraoperative and postoperative complications at m3, m6, m9, and m12 from device placement. To evaluate overall patient satisfaction, two validated questionnaires will be analyzed: the Oral Health Impact Profile (OHIP-14) and a Patient Satisfaction questionnaire. To assess the correlation between implant survival and certain systemic and clinical patient factors, the following independent variables will be studied: age, gender, smoking status, jaw in which the implants were placed, type of implant, implant length, implant diameter, and compared with implant survival data. Histological and histomorphometric analysis will be conducted on samples of regenerated bone collected during implant site preparation at the passage of the first preparation drill.