A randomized, controlled clinical trial to evaluate a new membrane for guided bone regeneration around dental implants

Abstract

The use of barrier membranes in guided bone regeneration (GBR) procedures for the treatment of alveolar bone defects is common practice. The objective of this study was to test whether a synthetic bioresorbable polyethylene glycol (PEG) hydrogel membrane could result in a similar amount of vertical bone fill as a standard collagen membrane, both combined with a membrane supporting material. The study enrolled 37 patients requiring implant treatment with an expected osseous defect in the posterior maxilla or mandible. After raising a mucoperiosteal flap, the implant sites were prepared and dental implants placed. The defect height was then measured and defects <3 mm were excluded from the study. Defects were grafted with bovine bone mineral and randomly covered with either a collagen membrane (control group, 18 patients) or a PEG hydrogel membrane (test group, 19 patients), which is applied as a liquid. After a healing period of 6 months, surgical re-entry was performed and the change in vertical bone height from baseline evaluated. Well-vascularized hard tissue was apparent at all sites and the regenerated bone was similar to the surrounding native bone. Mean vertical defect fill after 6 months was 5.63+/-1.84 mm at test sites and 4.25+/-1.16 mm at control sites, and the mean defect fills were 94.9% and 96.4% at test and control sites, respectively. More soft tissue complications were observed with the PEG membrane (e.g., delayed or incomplete wound healing) but all sites recovered uneventfully. The new PEG hydrogel membrane was as successful as a standard collagen membrane in the treatment of bony dehiscence defects around dental implants with simplified clinical handling.