Premixed Versus Manually Mixed Calcium Silicate-based Bioceramic Materials for Pulpotomy of Permanent Teeth with Irreversible Pulpitis: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

BACKGROUND

Calcium silicate-based bioceramic materials are widely used in vital pulp therapy because of their favorable biological and sealing properties. Premixed formulations were introduced to reduce operator-dependent variability associated with manually mixed materials; however, their comparative clinical performance in irreversible pulpitis remains unclear.

OBJECTIVES

To compare the clinical success of premixed versus manually mixed calcium silicate-based bioceramic materials used for pulpotomy procedures in permanent teeth with irreversible pulpitis.

METHODS

This systematic review and meta-analysis was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines and registered in PROSPERO (CRD420251110977). Electronic databases were searched from inception to August 2025. Randomized controlled trials comparing premixed and manually mixed calcium silicate-based materials in pulpotomy procedures for permanent teeth with irreversible pulpitis were included. Random-effects meta-analysis was performed to calculate pooled risk differences (RDs) and 95% confidence intervals (CIs). Statistical equivalence was evaluated using the two one-sided tests procedure with a predefined equivalence margin of ±10%. Bayesian analysis and multiple sensitivity analyses were additionally performed. Risk of bias was assessed using risk of bias 2 tool, and certainty of evidence was evaluated using Grading of Recommendations Assessment, Development and Evaluation.

RESULTS

Six randomized controlled trials involving 499 permanent teeth were included. No clinically meaningful differences were observed between premixed and manually mixed formulations at either 6 months (RD = 0.016; 95% CI: -0.039 to 0.071) or 12 months (RD = 0.004; 95% CI: -0.053 to 0.061), with negligible heterogeneity across analyses (I2 = 0%). Two one-sided tests analyses confirmed statistical equivalence at both follow-up periods (P < .001), with confidence intervals remaining entirely within the predefined ±10% equivalence margin. Bayesian analysis demonstrated moderate evidence favoring the null hypothesis of no treatment difference (BF01 = 4.20 at 6 months; BF01 = 3.67 at 12 months). Certainty of evidence was rated as moderate.

CONCLUSION

Premixed and manually mixed calcium silicate-based bioceramic materials demonstrated clinically equivalent outcomes following pulpotomy in permanent teeth with irreversible pulpitis. Given their comparable clinical performance, material selection may reasonably be guided by practical considerations such as handling characteristics, clinician preference, availability, and cost rather than expectations of superior clinical effectiveness.