Operative Times, Costs and Patient-Related Outcome Measures in Vertical Ridge Augmentation With Customised Reinforced PTFE Mesh Versus CAD/CAM Titanium Mesh: Secondary Analysis of a Randomised Clinical Trial.

Abstract

<h4>Aim</h4>This secondary analysis of a randomised clinical trial aimed to investigate vertical ridge augmentation (VRA) by comparing complication rates (primary outcome), times, costs and patient-reported outcome measures (PROMs) between customised Ti-reinforced PTFE mesh and customised CAD/CAM titanium mesh.<h4>Materials and methods</h4>Patients with vertical bone defects were randomly assigned to alveolar bone augmentation using either Ti-PTFE mesh or Ti mesh (T0). After 6-9 months, barriers were removed, and computer-guided surgery was performed to place implants in the augmented sites (T1). Complications, times, costs and PROMs (anxiety, pain, anti-inflammatory drug dosage, limitations in daily functions) were assessed and analysed.<h4>Results</h4>Forty-eight of 50 patients completed the bone augmentation surgery as per protocol. The estimated difference in healing complications was -0.04% (CI: -0.22 to 0.13), confirming the non-inferiority of Ti meshes to PTFE meshes. The estimated differences were -3.50 min (CI: -23.49 to 16.49) for total operative time (p = 0.688); €17.37 (-77.25 to 111.99) for costs (p = 0.130); -0.17 (CI: -0.80 to 0.47) for anti-inflammatory drug usage (p = 0.299); 0.56 (CI: -1.97 to 0.85) for pain levels (p = 0.565); and -0.13 (CI: -0.61 to 0.36) for limitations in daily functions (p = 0.528), on the day after surgery.<h4>Conclusion</h4>Outcomes were favourable, which encourage the use of both medical devices with low complication rates and both digital approaches, resulting in favourable operative times and PROMs.