Objective: To systematically evaluate and meta-analyze the short-and long-term clinical and radiologic failure rates of Biodentine versus formocresol as pulpotomy medicaments in primary teeth.
Data sources: Relevant medical databases were searched until May 2021 for randomized controlled trials that used Biodentine and formocresol as pulpotomy medicaments in primary teeth with deep caries. Primary outcomes included clinical and radiologic failure rates at 12 months. Secondary outcomes were clinical and radiologic failure rates at 3, 6, 9, 13 to 24, and 25 to 48 months.
Results: Nine randomized controlled trials (N = 626) with low risk of bias were included. Pooled analysis showed that compared to formocresol, Biodentine had significantly lower clinical failure rates (relative risk [RR] 0.16; 95% confidence interval (CI) 0.03 to 0.87; six randomized controlled trials; N = 394; GRADE, low) and radiologic failure rates (RR 0.19; 95% CI 0.08 to 0.49; six randomized controlled trials; N = 393; GRADE, low) at 12 months. Radiologic failure rates at 6 and 9 months were significantly lower in the Biodentine group compared to the formocresol group.
Conclusion: Compared to formocresol, Biodentine may be a superior medicament when used for pulpotomy in primary teeth. Adequately powered randomized controlled trials are needed to substantiate this evidence.