Clinical Evaluation of an Amalgam Replacement Restorative Material: 12-month Recall

Objectives: To compare posterior fillings with the ion-releasing Alkasite material Cention N (with and without adhesive) to amalgam restorations (Valiant) in a prospective, randomized, controlled clinical study.
Methods: 41 patients received 3 or 6 Class I or Class II restorations (126 restorations, 40% premolars, 60% molars, 29% Class I, 71% Class II): Cention N (with self-etching Adhese Universal adhesive), Cention N (without adhesive), one amalgam (Valiant). Restorations were evaluated by modified FDI criteria approximately 2wks (baseline), 6mos and 12mos after treatment. 12mos criteria were analyzed by Krusal-Wallis and Dunn’s post-hoc tests.
Results: 38 patients (111 restorations) were evaluated at 12mos recall (see table). Six restorative failures occurred: Cention N (without adhesive) due to retention loss at 6mos, Cention N (with adhesive) due to persistent hypersensitivity at 6mos, Valiant due to persistent post-op sensitivity at 12mos, Valiant due to cusp fracture at 12mos, Cention N (without adhesive) due to material fracture at 12mos, Cention N (with adhesive) due to periapical abscess at 12mos. Significant differences were seen between materials for surface luster (p<.01), surface staining (p<.01), marginal adaptation (p=.04), marginal staining (p<.01). Cention N without adhesive performed worse than Valiant in marginal staining (p<.01) and marginal adaptation (p=.37). Regarding marginal adaptation and staining, the percentage of 1 scores (excellent) was nominally higher for Cention N with adhesive than without. Cention N fillings had lower (p<.01) surface luster compared to Valiant, however, 80+% of the Cention N fillings were rated 1 or 2 for color match while Valiant was not evaluated in this category.
Conclusions: Overall, the ion-releasing Cention N scored 1 or 2 for over 90% of the restorations in all categories other than surface luster and color match. The results were largely similar to the amalgam restorations. Cention N with and without adhesive performed similarly but the restorations with adhesive tended to slightly higher scores.