Three-year prospective multicenter study evaluating marginal bone levels and soft tissue health around a one-piece implant system.

PURPOSE: The aim of this clinical investigation was to evaluate marginal bone remodeling and soft tissue health surrounding a novel one-piece implant system over a 3-year study period.

MATERIALS AND METHODS: Subjects missing at least one tooth in either arch were consecutively enrolled in this open prospective 3-year investigation. Five clinics were invited to participate. Strict inclusion and exclusion criteria were used. Marginal bone levels were evaluated using radiographs taken at implant insertion, 6 months, and annually thereafter. Plaque and bleeding indices were recorded at 3 and 6 months and 1 and 3 years following implant insertion. The shapes of papillae were evaluated at implant insertion with the provisional restoration in place, at the insertion of the definitive restoration, and at the 3-year follow-up, using Jemt's papilla index. Life tables and the Mann-Whitney U test were used for statistical analyses.

RESULTS: Fifty-six patients were restored with a total of 82 one-piece implants; 47 patients attended the 3-year appointment. One implant had to be removed 1 month postinsertion, giving a cumulative survival rate of 98.8% for the 3-year study period. Most bone resorption (mean, 1.19 ± 1.38 mm; n = 61) occurred during the first year of function, while there was minimal change in mean marginal bone levels between 1 and 3 years (-0.07 ± 1.07 mm; n = 58). Normal peri-implant mucosa was registered for more than 81% of the sites, and no visible plaque was registered for more than 54% of the sites.

CONCLUSION: This prospective 3-year multicenter study showed stable marginal bone levels, good soft tissue health, and a high implant survival rate, supporting the hypothesis that the presented one-piece implant system has the capacity to maintain both hard and soft tissues after the first year of initial bone remodeling.