Prospective Observation of a New Bioactive Luting Cement: 2‐Year Follow‐Up

Abstract

A pilot study was conducted to determine the 2-year clinical performance of a new bioactive dental cement (Ceramir C&B, formerly XeraCem) for permanent cementation. The cement used in this study is a new formulation class, a hybrid material comprising calcium aluminate and glass ionomer. Thirty-eight crowns and fixed partial denture (FPD) abutments were cemented in 17 patients. Thirty-one of the abutment teeth were vital, 7 nonvital. Six reconstructions were FPDs comprising 14 abutment teeth (12 vital/2 nonvital). A two-unit fixed splint was also included. Preparation parameters and cement characteristics (dispensing, working time, seating characteristics, ease of cement removal) were recorded. Baseline and postcementation data were recorded for marginal integrity, marginal discoloration, secondary caries, retention, and gingival inflammation. Tooth sensitivity was assessed at pre- and postcementation time points using categorical and visual analogue scale (VAS) assessment measures. Mixing of the cement was reported as "easy." Clinical working time for this cement was deemed acceptable. Assessment of seating characteristics indicated all restorations were seated completely after cementation. Cement removal was determined to be "easy." Fifteen of 17 subjects were available for 1-year recall examination; 13 patients were available for the 2-year recall examination. Restorations at 2-year recall examination included 17 single-unit, full-coverage crown restorations, four 3-unit FPDs comprising 8 abutments, and one 2-unit splint. No retentive failures or sensitivity were recorded at 2-year recall. Marginal integrities of all restorations/abutments at 2 years were rated in the "alpha" category. Average VAS score for tooth sensitivity decreased from 7.63 mm at baseline to 0.44 mm at 6-month recall, 0.20 mm at 1-year recall, and 0.00 mm at 2-year recall. The average gingival index score for gingival inflammation decreased from 0.56 at baseline to 0.11 at 6-month recall, then 0.16 at 1-year recall, and 0.21 at 2-year recall. Two-year recall data yielded no loss of retention, no secondary caries, no marginal discolorations, and no subjective sensitivity. All restorations rated "alpha" for marginal integrity at the 2-year recall. After periodic recalls up to 2 years, the new bioactive cement tested thus far has performed favorably as a luting agent for permanent cementation.