Evaluation of complication rates and vertical bone gain after guided bone regeneration with non‐resorbable membranes versus titanium meshes and resorbable membranes. A randomized clinical trial

Abstract

BackgroundThe partial edentulous posterior mandible is often a challenge area that requires a bone reconstructive surgery for implants placement.PurposeThis RCT was aimed to evaluate complications rate and vertical bone gain after Guided Bone Regeneration (GBR) with dense non‐resorbable d‐PTFE titanium‐reinforced membranes (Group A) versus titanium meshes covered by cross‐linked collagen membranes (Group B).Material and Methods40 partially edentulous patients with atrophic posterior mandible, were randomly divided into two study group: 20 patients were treated with one stage GBR by means of non‐resorbable d‐PTFE titanium‐reinforced membranes (Group A); and 20 patients, by means of titanium mesh covered by cross‐linked collagen membranes (Group B). All complications were recorded, distinguishing between “surgical” and “healing” and between “minor” or “major.”. Primary implants stability and vertical bone gain were also evaluated.ResultsIn the group A, surgical and healing complication rates were 5.0% and 15.0%, respectively. In the group B, surgical and healing complication rates were 15.8% and 21.1%, respectively. No significant differences between two study group were observed regarding complications rate implant stability and vertical bone gain.ConclusionsBoth GBR approaches for the restoration of atrophic posterior mandible achieved similar results regarding complications, vertical bone gain and implant stability.

Histological and histomorphometric analysis of bone tissue after guided bone regeneration with non‐resorbable membranes vs resorbable membranes and titanium mesh

“…The study population included 40 patients treated via the T0 protocol, but only 36 patients underwent reopening surgery in the T1 protocol because of complications and dropout, as reported previously . Six patients (three in each group) were excluded because it was impossible to obtain bone tissue from the regenerated area because of the risk that the bone supporting the implants might be damaged.…”

“…The study was conducted in accordance with all relevant principles of the Declaration of Helsinki and CONSORT guidelines. Since (a) the primary outcome of this randomized clinical trial was to compare complication rates of nonresorbable membranes vs resorbable membranes and titanium meshes, and (b) power analysis required a minimum of 17 patients (statistical power 80%, SD o = 1 and significant level of a = 0.05), the sample size was fixed at 20 patients in order to compensate possible drops‐outs, as reported in Cucchi et al…”

“…The surgical and prosthetic protocols used have been described previously by Cucchi et al . Briefly, bone augmentation and implant surgery (the T0 protocol) featured the following steps: flap elevation and passivation, cortical perforation with rounded burrs, bone harvesting using a bone scraper (Saferscraper; Meta, Reggio Emilia, Italy), creation of 50:50 bone mixtures of allografts (EnCore; Osteogenics Biomedical, Lubbock, Texas), and autogenous bone placement of one or more tapered implants with double‐variable threads and double‐acid‐etched surfaces (BT SAFE; Biotec SRL, Vicenza, Italy), opening of the randomization envelope and barrier selection, lingual fixation of Ti‐reinforced d‐PTFE membranes (Cytoplast Ti‐250XL; Osteogenics Biomedical) in group A or fixation of Ti‐mesh (Trinon Titanium, Karlsruhe, Germany) in group B, filling and adaptation of the biomaterial mixture, buccal‐side fixation using two or three mini‐screws (Pro‐fix Membrane Fixation Screws), placement of a cross‐linked collagen membrane (Osseguard; Zimmer Biomet, Warsaw, Indiana) over the mesh in group B, and free‐tension primary closure using PTFE sutures (Cytoplast sutures 250XL; Osteogenics Biomedical).…”

“…Considering the great variety of modern GBR techniques and materials, clinicians can predictably treat segmental or large bone defects caused by trauma, infection, or tumors, as well as horizontal and vertical defects, creating alveolar ridge shapes appropriate for ideal implant placement in the maxillofacial field . In the latter context, GBR may feature resorbable or nonresorbable barriers made of natural or synthetic polymers (such as native or cross‐linked collagen), respectively, or polytetrafluoroethylene (PTFE) or titanium mesh (Ti‐mesh) …”

Three-Dimensional Vertical Alveolar Ridge Augmentation in the Posterior Maxilla: A 10-year Clinical Study

“…3,7 However, with their use, a long time of graft healing up to 1 year is required, and an increased risk of dehiscences and infections is observed, which is found to have a detrimental effect on the regenerative outcome of the graft. 1,3,12,13 Allograft blocks are used as an alternative to autogenous grafts in a variety of different scaffolds to avoid donor site morbidity. 9,[14][15][16][17] Conclusions in published work concerning vertical alveolar ridge augmentation are based on a few trials including a low number of patients, sometimes having a short follow-up, and often being judged to be at high risk of bias.…”