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.

Immediate Dental Implant Stabilization in a Canine Model Using a Novel Mineral-Organic Adhesive: 4-Month Results.

PURPOSE: This study evaluated a novel injectable, self-setting, osteoconductive, resorbable adhesive that provides immediate implant stabilization. MATERIALS AND METHODS: Twenty-six large canines had the mandibular second through fourth premolars and the first molar removed bilaterally. After 3 months, oversized osteotomies were prepared with only the apical 2 mm of the implant engaging native bone. One site had a novel resorbable, self-setting, mineral-organic adhesive (TN-SM) placed around the implant, a second site received bone graft, and a third site received only blood clot. Removal torque, standardized radiography, and histology were used to evaluate implant stability and tissue contact after 24 hours, 10 days, and 4 months. RESULTS: Mean removal torque values after 24 hours were 1.4, 1.3, and 22.2 Ncm for the control, bone graft, and mineral-organic adhesive, respectively. After 10 days, these values were 5.7, 6.2, and 45.7 Ncm and at 4 months increased to 88.7, 77.8, and 104.7 Ncm, respectively. Clinical, radiographic, and histologic evaluations showed a lack of inflammatory reaction. Control defects were initially radiolucent in the coronal area; grafted sites revealed particles in the gap, with both conditions gradually filling with bone over time. At 10 days, histologic evaluation demonstrated excellent biocompatibility and intimate contact of mineral-organic adhesive to both the implant and bone, providing an osseointegration-like bond; control sites revealed no bone contact in the defect area, while the bone-grafted sites revealed unattached graft particles. At 4 months, much of the mineral-organic adhesive was replaced with bone; the control and grafted sites had some bone fill, and many of the defects demonstrated no bone-to-implant contact and were filled with soft tissue or isolated graft particles. CONCLUSION: The mineral-organic adhesive provides immediate (osseointegration-like) and continued implant stabilization over 4 months in sites lacking primary stability. Experimental sites demonstrated maintenance of crestal bone levels adjacent to the mineral-organic adhesive and soft tissue exclusion without the use of membranes in this canine model. These results demonstrate that this novel mineral-organic adhesive can enable implant osseointegration in a site where insufficient native bone exists to allow immediate implant placement.