One-year Practice-based Clinical Evaluation of a Low-Shrinkage Posterior Composite

Methods: Five members of the PROH practice-based research network each placed 10 composites in vital, permanent posterior teeth. Preparations without cavo-surface bevels received Optibond All-in-one adhesive and Premise (Kerr) restorations under rubber dam isolation. Each 2mm or less increment was cured for 40 seconds with an Optilux 501 (Kerr). Standardized finishing with abrasive discs and polishing points was accomplished; no surface sealant was placed. Restorations were evaluated at baseline (within two weeks after placement) and 12 months using modified Ryge (USPHS) criteria by the trained dentists who placed the restorations. Casts and photos were reviewed by evaluators not involved in restoration placement. Statistics were computed with Spearman's rank correlation coefficient and GEE, accounting for clustering among dentists (p≤0.05).

Results: 90% of restorations were class 2, 78% on molars. Restoration depth: shallow=10, moderate=39, deep=1. Restoration width: narrow=11, moderate=22, large=12, extensive=5. 28 were restored with a horizontal incremental technique, 22 with an oblique incremental technique. One restoration failed due to a proximal ridge fracture of the restoration. There was a significant positive correlation (p<0.001) between subjective cold sensitivity and restoration size (but not depth) at one year. There were no significant correlations between objective cold sensitivity and restoration size/depth. The only significant changes in the modified Ryge criteria from baseline to one year were in marginal integrity and marginal discoloration, both of which showed a transition from “R” to “S” rankings. Indirect assessment generally confirmed the practitioner findings.

Conclusions: Clinically acceptable performance of Premise was found after one year. Practitioner evaluations of their own work were confirmed by independent assessment, lending further validity to materials research in practice-based settings. Research supported by Kerr Corp.