Impact of Collagen Membrane in Vertical Ridge Augmentation Using Ti-Reinforced PTFE Mesh: A Randomised Controlled Trial.

Abstract

<h4>Aims</h4>This non-inferiority randomised clinical trial aimed to compare vertical bone gain (VBG), volumetric bone changes and incidence of complications after vertical ridge augmentation (VRA) using perforated titanium-reinforced dense-polytetrafluoroethylene (PTFE) mesh covered by a collagen membrane (CM) or used alone.<h4>Materials and methods</h4>Thirty patients with vertical bone defects were randomly assigned to receive VRA with either PTFE + CM or PTFE alone. Meshes were removed after 9 months. Clinical assessments included complication rates, pseudo-periosteum type and bone density. VBG, effective regeneration rate and the need for additional augmentation were evaluated using CBCT reconstructions.<h4>Results</h4>Non-inferiority of PTFE alone compared with PTFE + CM was not demonstrated for absolute and relative VBG (4.5 ± 2.1 mm vs. 4.1 ± 2.7 mm, 79.2% ± 16.6% vs. 85.8% ± 10.6%, respectively), effective regeneration rates (69.3% ± 17.9% vs. 72.3% ± 16.4%, respectively) or complication rates (6.7% in both groups). A higher incidence of type 1 pseudo-periosteum was observed in the PTFE + CM group.<h4>Conclusion</h4>The non-inferiority of PTFE alone compared with PTFE + CM for absolute VBG was not established. However, both techniques led to comparable outcomes for VBG, complication rates and bone density. The higher incidence of type 1 pseudo-periosteum and lacking bone volume in the PTFE + CM group suggests that adding a collagen membrane may help prevent soft tissue ingrowth.<h4>Trial registration</h4>Clinicaltrials.gov identification number: NCT04843488.