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
Abstract Objective 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. Materials and Methods 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]. Results 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%. Conclusions This study confirmed the non‐inferiority of customized CAD/CAM titanium meshes with respect to reinforced PTFE meshes in terms of surgical and…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 50 participants or records.
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