Clinical performance of a bioactive dental luting cement--a prospective clinical pilot study

To conduct a pilot study determining the clinical efficacy ofa new bioactive dental cement (Ceramir Crown & Bridge) for permanent cementation in fixed prosthodontics. The composition is a hybrid comprised of a calcium aluminate and a glass ionomer.

This study examined the performance of Ceramir Crown & Bridge after cementation of high-gold alloy and porcelain-fused-to-metal (PFM) single crowns and bridges. A total of 38 crowns and bridge abutments were cemented in 17 patients; 31 were on vital, seven on non-vital teeth. Six were bridges with 14 abutment teeth (12 vital/two non-vital). One fixed splint comprising two abutment teeth was also included in the study. Preparation parameters were recorded, as well as working time, setting time, seating characteristics, and ease of cement removal. Baseline data were collected on dispensing, mixing, and handling of the cement; gingival inflammation index (GI), and a visual analog scale (VAS) and categorical assessment measured pre-cementation sensitivity. Post-cementation parameters were post-cementation sensitivity, categorical and VAS, gingival tissue reaction, marginal integrity, and discoloration. A one-week post-op telephone call recorded subjectively the patients' comfort level.

Working time (two minutes) and setting time (four minutes) were well within normal limits. Cement removal was determined to be very easy. Thirteen of 17 patients reported no post-cementation sensitivity after seven days; four reported a low-grade sensitivity. All 17 patients were seen for recall examinations at 30 days and six months. Of the four sensitivity cases, three were related to hyperocclusion, which disappeared spontaneously after adjustment. One case was due to post-cementation pressure from a three-unit bridge, which disappeared without intervention. After six months, no retentive failures were recorded, no sensitivity was subjectively reported, marginal integrity scored 38 alphas, one tooth had a 1 and two teeth a 0.5 GI score. Average VAS score for tooth sensitivity decreased from 7.63 mm at baseline to 0.44 mm at the six-month recall. Average GI score for gingival inflammation decreased from 0.56 at baseline to 0.11 at the six-month recall.

After six months, Ceramir Crown & Bridge performed favorably as a luting agent for permanent cementation.