First clinical application of octacalcium phosphate collagen composite on bone regeneration in maxillary sinus floor augmentation: A prospective, single‐arm, open‐label clinical trial

Abstract

The overall objective of this study was to assess the safety and efficacy of OCP/Col as a bone substitute material for bone regeneration during sinus floor augmentation. Maxillary sinus floor augmentation was performed thorough lateral window approach. According to the height of host bone, simultaneous approach (≥5 mm) or staged approach (less than 5 mm) was applied. In this research, clinical findings of dental implant treatment after setting the restorations were set as a primary endpoint in both approaches (infection, inflammation around the implant, movement of the implant, pain, sensory disorder, and bone resorption around the implant body on radiological evaluation.). In staged approach, histological evaluation of bone biopsy specimen was also conducted. As secondary endpoints, hounsfield unit (HU) value, vertical bone height, implant stability quotient (ISQ), and adverse events during the research were evaluated. In all cases, as a primary endpoint, clinical findings after setting the restorations were uneventful with no adverse events. Histological structure demonstrated mature bone derived from OCP/Col. In the ossified area, osteogenesis was observed around OCP granules, and osteoblast‐like cells were arrayed around OCP granules. Osteocyte encapsulation was recognized in the new bone. HU increased over time with both approaches. Vertical bone height significantly increased at 3 months postoperatively, and maintained during follow‐up. ISQ increased with both approaches. In particular, ISQ was significantly increased with the staged approach. This clinical trial demonstrated the safety and efficacy of OCP/Col for bone regeneration in maxillary sinus floor augmentation. © 2019 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 108B:243–252, 2020.

Influence of pre‐freezing conditions of octacalcium phosphate and collagen composite for reproducible appositional bone formation

“…OCP/Col has also promoted osteogenic differentiation and angiogenesis (Kouketsu et al, 2020). After the confirmation of its safety and efficacy in preclinical studies with bone defects (Kawai et al, 2011; Matsui et al, 2010; Matsui et al, 2014; Tanuma et al, 2013), doctor‐initiated and sponsor‐initiated clinical trials were conducted (Kawai et al, 2014, 2016, 2017; Miura et al, 2020), and the commercialization of OCP/Col in Japan was recently approved for the bone defects in the field of oral surgery (Kamakura, 2020; Kawai et al, 2020).…”

Bone Regeneration by Low-dose Recombinant Human Bone Morphogenetic Protein-2 Carried on Octacalcium Phosphate Collagen Composite

“…OCP/Col was shown to yield significantly enhanced bone regeneration compared with β-TCP or HA collagen composite 14) . OCP/Col has also been shown to be both safe and efficacious in human tooth extraction sockets, cystic cavities, and maxillary sinus floor elevation [15][16][17][18] . BMP-2 is known to absorb calcium phosphate and Correspondence to: Dr. Kei-ichiro Miura, Department of Regenerative Oral Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan, 1-7-1, Sakamoto, Nagasaki 852-8588, Japan; Phone: +810958197704; E-mail: kei.miura.e.mail@gmail.com also collagen 19,20) .…”

Segmental Bone Reconstruction by Octacalcium Phosphate Collagen Composites with Teriparatide

“…It has promoted osteogenic differentiation and angiogenesis, 15 and exhibited excellent bone regenerative properties in preclinical studies. [16][17][18] Also, it showed good safety and efficacy in clinical situations, [19][20][21][22] and was recently commercialized in Japan. 23,24 Parathyroid hormone (PTH) regulates the metabolism and functions of calcium and phosphate, 25 and teriparatide (TPTD) is a recombinant form of PTH consisting of the bioactive portion of the N-terminal fragment comprising 34 amino acids.…”