Direct pulp capping of primary molars using a novel fast-setting calcium silicate cement: a randomized clinical trial with 12-month follow-up.

Novel fast-setting calcium silicate cement with fluoride (Protooth) has been developed for potential applications in tooth crowns. The aim of this study was to evaluate the success rate of direct pulp capping in primary molars using two-layer mineral trioxide aggregate (MTA) and overlying glass ionomer cement versus one-layer novel calcium silicate cement with 4 to 10 minutes setting time. Ninety bilaterally symmetrical primary molars in the same jaw in 45 patients aged 5 to 7 years were included. Exposed pulps following caries removal were randomly capped with one-layer novel calcium silicate cement or two-layer MTA and glass ionomer cement. All cavities were filled with amalgam. Clinical and radiographic evaluations were performed after six and twelve months. 41 patients were available for the evaluations at the end of the 12-month follow-up. The overall success rate of direct pulp capping, in a split-mouth design, using MTA covered with glass ionomer cement or one-layer novel calcium silicate cement after 12 months were 90% (37 out of 41 cases) and 85% (35 out of 41 cases), respectively, without statistically significant differences after 6 and 12 months. Within the limitations of this study, clinical and radiographic evaluations suggested one-layer novel calcium silicate cement would be successfully used in direct pulp capping of primary molars as a practical alternative to two-layer MTA and overlying glass ionomer cement.