Sinus floor elevation using particulate PLGA‐coated biphasic calcium phosphate bone graft substitutes: A prospective histological and radiological study

Abstract

Background Poly (lactic‐co‐glycolic acid) (PLGA) is widely used for the development of delivery systems for drugs and therapeutic biomolecules in tissue engineering applications. Particles of biphasic calcium phosphate can be covered by PLGA to change their manipulating characteristics. Purpose Aim of this study was to investigate the radiological and histomorphometric results of the use of PLGA‐coated biphasic calcium phosphate granules in sinus floor elevation and to analyze the underlying molecular processes by immunohistochemical staining. Materials and Methods A randomized clinical study was designed to include patients in need of sinus floor elevation. Patients were assigned to receive either PLGA‐coated biphasic calcium phosphate particles (group I) or the equivalent but noncoated particles (group II). Cone beam computed tomography (CBCT) scans were performed before and 6 months after the procedure to assess the bone height gain. At the time of implant placement, bone core biopsies were obtained at the site of implant placement. Histological sections were subjected to histomorphometric and immunohistochemical evaluation of differentiation markers (Musashi‐1 [MSI1]). Results No statistically significant differences were observed between groups for the radiologic parameters. No differences were observed histologically or histomorphometrically. However, PLGA‐coated particles (group I) were more colonized by MSI1‐positive osteoblast precursors (P = 0.0001, chi‐squared test) and were penetrated by more CD34‐positive vascular structures (P = 0.001, chi‐squared test) than noncoated particles (group II). Conclusions PLGA‐coated particles are associated with more MSI11‐positive cells and more extensive microvascularization than noncoated particles.

Biphasic hydroxyapatite and ß‐tricalcium phosphate biomaterial behavior in a case series of maxillary sinus augmentation in humans

“…Similarly, 26.9 ± 5.4% and 29.3 ± 9.1% of remaining biphasic calcium phosphate particles have been observed in similar studies (Ohayon, ; Ohayon et al, ). More recently, Flichy‐Fernández found the persistence of 22.0 ± 17.26% of a similar biphasic calcium phosphate biomaterial (Flichy‐Fernández et al, ).…”

Algae‐derived hydroxyapatite behavior as bone biomaterial in comparison with anorganic bovine bone: A split‐mouth clinical, radiological, and histologic randomized study in humans

“…In fact, we have detected that MSI1 and RUNX2 follow a similar expression pattern during osteogenic differentiation of MSC derived from the oral cavity (Padial‐Molina et al, 2019). MSI1‐positive fibroblast‐like cells in regenerated areas in humans have been demonstrated in other families of biomaterials, as allografts (Galindo‐Moreno et al, 2018) and synthetic materials (Flichy‐Fernández et al, 2019; Olaechea et al, 2019). In the present study, we have also found a statistically significantly higher number of MSI1‐positive cells per mm 2 in the non‐mineralized component of the grafted areas surrounding both combinations of biomaterials.…”

Evaluation of Poly Lactic-co-Glycolic Acid-Coated β-Tricalcium Phosphate Bone Substitute as a Graft Material for Ridge Preservation after Tooth Extraction in Dog Mandible: A Comparative Study with Conventional β-Tricalcium Phosphate Granules

“…Moreover, NMP is flushed out upon contact with body fluids after the application of PLGA/β-TCP, suggesting that NMP may have a short-term cytotoxic effect [ 20 ], and would therefore not affect bone regeneration at 12 weeks post-operatively. Furthermore, preclinical and clinical studies comparing PLGA-coated biphasic calcium phosphate granules to the identical uncoated biphasic calcium phosphate granules showed no negative effects of the PLGA coating nor the addition of NMP [ 13 , 14 ]. This result suggests that the coating is unlikely the cause of the delayed bone formation.…”

“…In terms of β-TCP used in this study, it was better to use the identical β-TCP if the objective of the present study was the analysis of the effect of PLGA and/or NMP on bone regeneration. However, it was already studied in the previous study referred above [ 13 , 14 ]. Then, we thought it was reasonable to evaluate the safety and efficacy of PLGA/β-TCP for alveolar ridge preservation in extraction sockets compared to an already authorized material, because we aimed to get marketing authorization of the PLGA/β-TCP.…”

“…The suitability of this material for ridge preservation has been clinically reported [ 1 , 8 , 9 , 10 , 11 , 12 ]. However, the impact of polymers on the resorption/replacement of PLGA/β-TCP and the negative effect of PLGA and NMP during wound healing of a tooth extraction socket are currently unknown, though there have been no negative effects reported in maxillary sinus floor augmentation both in an animal and a clinical study [ 13 , 14 ].…”