Twelve-month evaluation of a novel mineral–organic adhesive material used to stabilize dental implants placed in oversized osteotomies in vivo in an animal model

Objectives: The aim of this study is to evaluate long-term in vivo stability of dental implants stabilized at time of placement in oversized osteotomies with a novel, self-setting, mineral–organic bone adhesive. Materials/Methods: Canine (26) mandibular teeth were removed, and three oversized osteotomies prepared bilaterally. Implants were placed with either adhesive, particulate xenograft, or with blood clot filling the implant/osteotomy gaps. Removal torque and histology were assessed. Results: The adhesive provided significant and clinically relevant immediate implant stability of 22.2 N-cm (95% CI 5.3; 39.0), which continued throughout the early postoperative course and persisted through the nine- (155 N-cm 95% CI 113; 197) and 12-month (171 N-cm 95% CI 134.2; 209.4) time points. This is in comparison with the blood clot of 1.4 N-cm (95% CI 0.7; 2.1), 128.6 N-cm (95% CI 66.8; 190.4), and 140.7 N-cm (95% CI 78.8; 202.5) and particulate xenograft, 1.3 N-cm (95% CI 0.6; 2.0), 132.1 N-cm (95% CI 94.5; 169.7), and 101.5 (95% CI 59.5; 143.5), respectively. Histological examination shows the adhesive establishes intimate contact with the implant and bony walls and is replaced with new bone without compromising stability. Soft tissue does not penetrate the adhesive, and marginal bone/biomaterial level is maintained. Control sites filled with xenograft or blood clot heal with reduced bone levels, and in some cases, xenograft particles were encapsulated in connective tissue. Conclusions: Implants placed in oversized osteotomies and lacking primary stability can be stabilized at placement with a novel, highly osteoconductive, and resorbable adhesive. Gradual replacement of the biomaterial allows osseointegration without loss of stability through 12 months of follow-up. This novel adhesive has the potential to stabilize implants placed in sites with inadequate bony support.