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.
Use of the synthetic resorbable dental membrane together with bone filler granules in a fenestration at the implant apex site. (a) Preoperative view. (b) Intra-operative view showing the fenestration. (c) Implantation of the membrane after filling the defect with biomaterial granules. (d) 14 days postsurgery view of soft tissue healing. (e) 4 months postsurgery view. (f) Retro-aveolar radiograph at 4 months postsurgery.
Use of the synthetic resorbable dental membrane together with bone filler granules in a bone dehiscence during implant insertion. (a) Preoperative view. (b) Intra-operative view showing the dehiscence. (c) Implantation of the membrane after filling the defect with biomaterial granules. (d) Sutures at end of surgery. (e) 14 days postsurgery view of soft tissue healing. (f) Retro-alveolar radiograph at 4 months postsurgery.
Alveolar ridge augmentation in anterior sector using the synthetic resorbable dental membrane together with bone filler granules before dental implants. (a) Intra-operative view showing the defect after extraction of tooth #11. (b) Placement of the membrane. (c) Filling of the defect with biomaterial granules. (d) 14 days postsurgery view of soft tissue healing. (e) Insertion of 2 dental implants 6 months after augmentation. (f) Final prosthetic rehabilitation.
Dentist satisfaction score for using the synthetic resorbable dental membrane in 26 patients at time of surgery and 4 months postoperatively (mean ± SD, *statistical significance with P = .007567).
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