Safety and efficacy of a novel, gradually anodized dental implant surface: A study in Yucatan mini pigs.

BACKGROUND: A newly developed dental implant system combining advancements in surface chemistry, topography, nanostructure, color, and surface energy aims to address biological challenges and expand clinical applications.

PURPOSE: To assess the short- and long-term safety and efficacy of a novel, gradually anodized dental implant surface/anodized abutment.

MATERIALS AND METHODS: Twenty-four Yucatan mini pigs (20-24 months old) received two dental implants in each jaw quadrant. Each site was randomized to receive either a commercially available anodized implant/machined abutment or a gradually anodized implant/anodized abutment with a protective layer. Animals were euthanized at 3, 6, and 13 weeks. Microcomputed tomography and histological analyses were performed.

RESULTS: No significant histological differences in inflammation scores, epithelium length, bone-to-implant contact, or bone density were observed between groups for any healing time. Mucosal height was significantly higher at 3 weeks for controls (Δ = 0.2 mm); no differences were observed at 6 and 13 weeks. No significant differences in radiographic bone volume, bone-to-implant contact, trabecular thickness, and crestal bone levels were observed, irrespective of healing time. Trabecular spacing was borderline significant at 3 weeks in favor of the test implant sites; no differences were observed at 6 weeks. No significant differences were observed between experimental groups at 13 weeks.

CONCLUSIONS: The new implant system yielded results comparable to a commercially available predicate device.