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

Author:

Cucchi Alessandro1ORCID,Bettini Sofia23,Tedeschi Lucia1,Urban Istvan4,Franceschi Debora5ORCID,Fiorino Antonino6,Corinaldesi Giuseppe7

Affiliation:

1. Private Practice Bologna Italy

2. Implant Center for Edentulism and Jawbone Atrophies, Maxillofacial Surgery and Odontostomatology Unit Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy

3. Department of Biomedical, Surgical and Dental Sciences University of Milan Milan Italy

4. Department of Periodontology and Oral Medicine University of Michigan Ann Arbor Michigan USA

5. Department of Experimental and Clinic Medicine University of Florence Florence Italy

6. Department of Neuroscience and Reproductive and Odontostomatological Sciences ‘Federico II’ University of Naples Naples Italy

7. Department of Biomedical and Neuromotor Sciences (DIBINEM) University of Bologna Bologna Italy

Abstract

AbstractObjectiveThe 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 MethodsFifty 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].ResultsOf 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%.ConclusionsThis 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.

Publisher

Wiley

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