Pilot Study on the Effectiveness of a Flexible Hydroxyapatite-Based Composite for Jaw Bone Regeneration
NCT Number: NCT06552715
Acronym: Flexi2024
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Bone Atrophy|Edentulism|Bone Regeneration
Interventions: DEVICE: Placement of resorbable HAp-based composite
Sponsor: University of Bologna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-09
Locations: Dental Clinic, Unit of Oral Surgery, University of Bologna, Bologna, 40125, Italy

Summary:
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 real-life biomechanics. 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.

Primary Outcome Measures: Regenerated Bone Volume, he 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. It is specified that CBCT scans and the procedure are performed as part of routine clinical practice., From the treatment and after 8 months,
Secondary Outcome Measures: Complications, Any pathological events such as neurological lesions, exposures or infections of the placed medical device, inflammation, fractures or loosening of prosthetic screws, prosthesis fracture, etc., reported in the clinical record and occurring during or after implant placement and throughout the clinical follow-up (m1; m3; m6; m8; and m12 from the surgical placement of the device) will be evaluated as outcomes of intraoperative and postoperative complications., Months 1, 3, 6, 8, and 12.|Patient Satisfaction, To evaluate the overall satisfaction of patients undergoing the treatment, a validated questionnaire, the Oral Health Impact Profile (OHIP-14), is completed by patients during follow-up visits. The same questionnaire will be administered to patients one month after the surgical procedure and eight months after the procedure. OHIP is a 14-item questionnaire., At 1 month and 9 months after treatment|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 (m6, m12, and 3 years), After Treatment for 3 years|Histological analysis, Histological analysis on samples of regenerated bone collected during the preparation of the implant site, specifically during the passage of the first preparation drill. Paraffin sections will be cut at 4 µm, fixed in formalin, and mounted on slides treated with 3-aminopropyltriethoxysilane. The sections will then undergo immunostaining for blood vessels using antibodies against CD31, VEGF, and KDR epitopes.The criteria established by Weidner and Folkman will be used to identify blood vessels in the immunostained sections. Specifically, positively stained endothelial cells or groups of endothelial cells, regardless of shape and size, that are clearly separated from adjacent blood vessels or other connective tissues, will be counted as blood vessels. Vascular nodules, although usually present, will not be considered a definition of a blood vessel, and red blood cells will not be used to calculate the vascular lumen., 8 months after device placement.|Hard Tissues Conditions, The condition of hard tissues is assessed based on periapical intraoral radiographs, taken using the parallel technique before and after the preservation procedure, at the time of implant placement, at the initial loading, and at the final prosthetic loading and various follow-ups., At months: 3, 6, 12 and 3 years after treatment|Peri-implant probing depth (PPD) in mm, The condition of soft tissues is evaluated using periodontal indices and recorded in the clinical record: using a periodontal probe, the peri-implant probing depth (PPD) will be evaluated in millimiters, and the are measured for each implant site (at m3, m6, m12, and 3 years post-implant placement)., At months: 3, 6, 12 and 3 years after treatment|bleeding on probing (BOP),, Using a periodontal probe, the presence of bleeding around the implants will be recorded in the clinical record., At months: 3, 6, 12 and 3 years after treatment|Amount of keratinized gingiva, Using a periodontal probe, the amount of keratinized gingiva will be assessed in millimiters and recorded in clinical record., At months: 3, 6, 12 and 3 years after treatment