Complication, vertical bone gain, volumetric changes after vertical ridge augmentation using customized reinforced PTFE mesh or Ti-mesh. A non-inferiority randomized clinical trial.

Abstract

<h4>Objective</h4>The aim of this non-inferiority randomized clinical trial was to compare the surgical and healing complications, vertical bone gain, and volumetric bone changes after vertical ridge augmentation using two different approaches: customized Ti-reinforced d-PTFE mesh versus customized CAD/CAM Ti-mesh.<h4>Materials and methods</h4>Fifty patients with vertical bone defects were randomly treated with Ti-reinforced d-PTFE mesh (control group) or CAD/CAM Ti-mesh (test group) and a mix of autogenous bone and deproteinized bovine bone matrix. Surgical and healing complication rates (SCR-HCR), vertical bone gain (VBG), regenerated bone volume (RBV), and regeneration rates (RR and ERR) were recorded and analysed [significance level (α) of 0.05].<h4>Results</h4>Of the 50 patients, 48 underwent bone augmentation surgery. SCR were 4% and 12% in PTFE and Ti-mesh, whereas HCR were 12.5% and 8.3%. VBG were 5.79 ± 1.71 mm (range: 3.2-8.8 mm) in the PTFE group and 5.18 ± 1.61 mm (range: 3.1-8.0 mm) in the Ti-mesh group (p = .233), whereas RBV were 1.46 ± 0.48 cc and 1.26 ± 0.55. RR was 99.5% and 87.0%, demonstrating a statistically significant difference (p = .013). Finally, the values related to pseudo-periosteum, bone density, and implant stability were similar in the two study groups. Osseointegration rates were 98.2% and 98.3%.<h4>Conclusions</h4>This study confirmed the non-inferiority of customized CAD/CAM titanium meshes with respect to reinforced PTFE meshes in terms of surgical and healing complications. Although PTFE meshes showed higher vertical bone gain and regeneration rates than Ti-meshes, no significant differences were found.