A Randomized Controlled Clinical Trial of the Performance of Three Bioactive Endodontic Cements in Primary Molar Teeth Diagnosed with Reversible Pulpitis: 1-Year Follow-Up Study.

OBJECTIVES: The objective of this clinical trial was to evaluate and compare the clinical and radiographic successes of three bioactive endodontic cements (BEC) including novel portland cement-based material releasing fluoride, resin-modified silicate glass cement, and pure tricalcium silicate-based cement-in the treatment of primary molars diagnosed with reversible pulpitis via indirect pulp capping. METHODS: Eighty-six (86) participants with previously untreated first and second primary molars were included in this study. The teeth were randomly allocated into three groups: pure tricalcium silicate-based cement, resin-modified silicate glass cement, and novel portland cement-based material releasing fluoride. Cavities were capped with the assigned cement after caries excavation using standard protocols. The teeth that underwent treatment were restored using glass ionomer cement and composite resin. Clinical and radiographic evaluations were performed at 1, 6, and 12 months. The data were analyzed using Pearson chi-square, Kruskal-Wallis H and Z test (P = 0.05). RESULTS: The success rate was 88% (n=25) in the pure tricalcium silicate-based cement group, 88.5% (n=26) in the resin-modified silicate glass cement group, and 100% (n=25) in the novel portland cement-based material releasing fluoride group. The differences at the 1st, 6th, and 12th month follow-up visits were not statistically significant among the groups (P>0.05). No difference was found between the integrity of the resin composite restorations overlying pure tricalcium silicate-based cement, resin-modified silicate glass cement, and novel portland cement-based material releasing fluoride according to the USPHS criteria. CONCLUSIONS: Novel portland cement-based material releasing fluoride can be considered an alternative for preserving the tooth, as it showed a high success rate in treating primary molars diagnosed with reversible pulpitis via indirect pulp capping. CLINICAL SIGNIFICANCE: Novel Portland cement-based material releasing fluoride could be beneficial in the treatment of primary molars diagnosed with reversible pulpitis via indirect pulp capping.