Clinical Safety of a New Synthetic Resorbable Dental Membrane: A Case Series Study.

Dental membranes are commonly used in oral and maxillofacial surgery for the regeneration of small osseous defects. A new synthetic resorbable membrane has recently demonstrated its biocompatibility and bone regeneration capacity in preclinical studies. This membrane is made of poly(D,L-lactic/glycolic acid 85/15), has a bi-layered structure with a dense film to prevent gingival epithelial cell invasion, and a microfibrous layer to support osteogenic cells and bone healing. This membrane completely degrades by hydrolysis in 4 to 6 months without signs of inflammation. Based on this research, a clinical study was conducted to evaluate the safety of the new membrane in guided tissue regeneration (GTR). In total, 26 patients (age: 50.5 +/- 12.4, min-max 31-72 years; male/female 42/58%) were operated on at 7 independent private dental practices. Dental surgeons used the membrane together with various bone fillers in GTR for immediate and delayed implant placement (23 cases, 88%) and, to a lesser extent, socket preservation (2 cases, 8%) and alveolar crest augmentation (1 case, 4%). Surgeons reported an easy placement of the membrane (satisfaction index: 3.8/5). Fourteen days postsurgery, 15 patients had no pain while the others declared minimal pain (verbal rating scale: 2.2/10), and none had minor or serious complications related to the membrane. Exposure of the membrane without loosening the biomaterial granules was observed in 3 cases while mucosa healed normally over time. At 4 months postimplantation, no infection or mucosal inflammation was reported, and the overall dentist satisfaction with the clinical performance of the membrane was 4.5/5 on average. This clinical study demonstrated that the new synthetic resorbable membrane is safe for guided bone tissue regeneration in various dental surgery indications.