A Prospective Study of the Assessment of the Efficacy of a Biodegradable Poly(l-lactic acid/ε-caprolactone) Membrane for Guided Bone Regeneration

Abstract

Biodegradable guided bone regeneration (GBR) membranes consist primarily of collagen and aliphatic polyesters. This study assessed the comparative efficacy of a poly(l-lactic-caprolactone) [P(LA/CL)] membrane versus that of a collagen membrane in GBR. Patients requiring GBR simultaneously or before dental implant placement in edentulous regions were randomly assigned to one of two membranes. Within each membrane, they were subdivided into 3 groups: dental implants were placed simultaneously with GBR in groups A and B, and 180 days post-GBR in group C. The augmented bone width was measured at 1, 3, and 6 mm from the implant’s neck (groups A and B) or the reference line (group C), utilizing cone-beam computed tomography images, immediately and 150 days post-surgery. A histological study was performed to evaluate bone formation in group C. No adverse events were observed. In the collagen group, the absorbed ratios of the augmented bone were 40.9 ± 36.7%, 29.4 ± 30.1%, and 11.1 ± 22.0% at 1, 3, and 6 mm, respectively; the ratio at 6 mm was significantly lower than that at 1 mm (p = 0.0442). In the P(LA/CL) group, those were 26.2 ± 27.3%, 17.1 ± 19.7%, and 13.3 ± 16.4% at 1, 3, and 6 mm, respectively, with no significant difference at each point. No significant inter-membrane differences were observed. The bone augmentation potential of the P(LA/CL) membrane matched that of the collagen membrane. P(LA/CL) could be used as a safe and effective membrane in GBR.

Barrier Effects of a Novel Poly (Lactic acid/Caprolactone) Bilayer Membrane for Guided Bone Regeneration on Skull without Periosteum of Adult-Senior Staged Rats

“…Especially, bone morphogenetic proteins (BMPs) in bone matrix are key growth factors for accelerated bone formation in GBP procedure. BMPs has a strong boneinducing capability, and vertical bone augmentation was achieved at 3 weeks by onlay implant using the composite of recombinant human BMP-2 (10 μg) and atelocollagen material (10 mg) on adultsenior staged rat skull model without periosteum [13]. We propose the application of the P(LA/CL) membrane including recombinant human BMP-2 in the porous layer and the highly porous HAp block combined with recombinant human BMP-2 onto the perforated outer cortical bone in this onlay model for an ideal GBR therapy.…”

“…Already, safety and feasibility of the P(LA/CL) membrane with carbonate apatite granules and autogenous bone was clinically assessed for GBR in bone defects surrounding dental implants in human pilot study [12,13]. In brief, 5 patients for GBR were included in the first-in-human study.…”

“…The patients required GBR procedure simultaneously or before dental implant placement in edentulous regions. The clinical results indicated that the P(LA/CL) membrane with carbonate apatite granules achieved reasonable bone regeneration for implant placements [13]. However, the fate and behavior of the P(LA/CL) membrane in the applied sites were not mentioned in the clinical papers [12,13].…”