Objectives:~to evaluate the effectiveness of digitally customized titanium meshes for guided bone regeneration with autologous bone chips taken from the mandibular body and/or ramus mixed with bovine bone mineral bone granules (500-1000microns in diameter):~complication rate of the reconstructive procedure;~assessment of bone gain obtained before implant placement;~implant survival and implant-related complications 1 year after the starting of prosthetic loading;~peri-implant bone resorption (MBL) after 1 year from the prosthetic load.~to perform a histomorphometric analysis of bone samples taken from sites reconstructed according to the principle of Guided Bone regeneration by means of autologous bone chips mixed with a xenograft with a 1:1 ratio and customized titanium mesh.~The following parameters will be analyzed from an histologic point of view:~bone remodeling and mineralization levels of the new bone matrix~volumetric tissue fractions~neo-vascularization~Study method: prospective study - 24 consecutive patients treated (see statistical power analysis)~The study will be performed in accordance with the ISO Standard 14155: 2011, Clinical Investigation of Medical Devices for Human Patients with the Appendices VIII and X of the Medical Device Directive 93/42/ EEC and following the 2004 Helsinki Declaration.~The null hypothesis (H0) is the following: the reconstructed bone is not functionally mature to support implants, masticatory and functional loads after 12 months.~The sample size calculation was performed with the statistical program https://clincalc.com/stats/samplesize.aspx. A literature search on PubMed was performed and revealed that, on average, the percentage of new bone formed after reconstructions with particulate bone autografts and xenografts and titanium mesh is 66% with a standard deviation of 6%. The expected percentage value for the investigator's study was set at 70% with a statistical power of 90% and a two-tier significance level of 0.05.~Data distribution will be analyzed by Shapiro Wilk's normality test, due to the small sample size.~If the data distribution is normal, the comparative analysis for the primary outcome will be performed by T-student test for paired samples. If the data distribution is not normal, a Wilcoxon test will be performed.~The independent variable of the study is the bone reconstruction procedure. The dependent variables are: a) the histomorphometric values of the reconstructed bone; b) the increase (measured in mm) of the bone reconstruction obtained; c) the MBL (in mm) peri-implant 1 year after the prosthetic load.~Data analysis will be performed with SPSS software. Differences will be considered statistically significant for alpha <0.05.
The aims of this prospective clinical study are to evaluate: a) the effectiveness of digitally customized titanium meshes in association with autologous bone particles and bovine bone mineral and covered with collagen membranes for the regeneration of atrophic edentulous sites; b) the survival rate of implants placed in the reconstructed areas; and c) new bone regeneration from a histomorphometric point of view