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
ABSTRACT Aim 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. Materials and Methods 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. Results 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. Conclusion Outcomes were favourable, which encourage the use of both medical devices with low complication rates and both digital approaches,…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 50 participants or records.
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