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

Kei ichiro Miura, Yoshinori Sumita, Fumihiko Kajii, Hidenori Tanaka, Shinji Kamakura, Izumi Asahina

Research output: Contribution to journalArticlepeer-review

7 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)243-252
Number of pages10
JournalJournal of Biomedical Materials Research - Part B Applied Biomaterials
Volume108
Issue number1
DOIs
Publication statusPublished - 2020 Jan 1

Keywords

  • biomaterial
  • bone regeneration
  • maxillary sinus floor augmentation
  • octacalcium phosphate
  • tissue engineering

ASJC Scopus subject areas

  • Biomaterials
  • Biomedical Engineering

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