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

Abstract

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.

Prospective randomized controlled clinical trial to compare hard tissue changes following socket preservation using alloplasts, xenografts vs no grafting: Clinical and histological findings

“…Mozzati and colleagues reported, following socket preservation procedure with biomimetic nanostructured matrix that patients reported pain scores were ≤4. Most recently (2018) Martin‐Thome and colleagues in a private practice setting, using a barrier membrane for socket preservation and bone augmentation, reported very similar pain scores (mean 2.2).…”

Healing Process with the use of a New Resorbable Synthetic Membrane

“…A resorbable synthetic medical grade poly-lactic-glycollic acid membrane (PLGA, Tisseos ® , Biomedical Tissues, France) was used in all cases. This membrane has a total thickness of 450 µm and a bilayered structure with a thin dense film intended to face soft tissues and a microfibrous layer for guiding bone regeneration [9,10]. It maintains its structural integrity and barrier effect for two months and is completely degraded by hydrolysis in 4-6 months [9].…”

“…This new membrane has a bi-layered structure with a dense film to prevent gingival fibroblast ingrowth and ensure mechanical function, and a microfibrous layer to support colonization by osteogenic cells and promote guided bone regeneration. The biofunctionality of this membrane was evidenced in different animal models of bone regeneration of critical size defects as well as in patients [9,10].…”

Biocompatible Materials in Otorhinolaryngology and Their Antibacterial Properties

“…This membrane is made of poly-D,L-lactic/glycolic acid 85/15 (PLGA) and completely degrades by hydrolysis after 4–6 months without signs of inflammation and has a bi-layered structure with a dense film to prevent gingival epithelial cell invasion and a micro-fibrous layer to support osteogenic cells and bone healing. Re-epithelialisation and normal wound closure were observed in patients, where the membrane was exposed after surgery [ 101 ].…”