Chitosan pulpotomy medicaments versus conventional agents in primary teeth: a systematic review and meta-analysis

BACKGROUND: Vital pulpotomy is routinely performed to maintain radicular pulp vitality in carious primary molars, yet the long‑standing use of formocresol persists despite concerns about potential cytotoxic, mutagenic, and systemic effects. Chitosan, a naturally derived polysaccharide with antibacterial, hemostatic, and regenerative properties, has been proposed as a more biocompatible pulpotomy medicament. OBJECTIVE: To evaluate the radiographic and clinical results of conventional and chitosan-based pulpotomy medicaments (formocresol, ferric sulfate) in primary molars, based exclusively on randomized controlled trials. METHODS: From database inception to January 15, 2026, a PRISMA-compliant systematic review and meta-analysis of randomized controlled trials was carried out in PubMed, Web of Science, Scopus, and the Cochrane Library. Cochrane RoB 2 was used to evaluate the risk of bias, and GRADE was used to score the certainty of the evidence. Mantel-Haenszel random-effect model was used to aggregate six-month clinical and radiographic success as risk ratios (RR) with 95% confidence intervals (CI). RESULTS: Four parallel‑group trials from India, involving 196 primary molars in children aged 4-9 years, met the inclusion criteria. Six‑month clinical success was identical for chitosan and conventional agents (83/86, 96.5% vs. 83/86, 96.5%; RR 1.00, 95% CI 0.94-1.06; I² = 0%), and radiographic success was likewise comparable (76/85, 89.4% vs. 73/85, 85.9%; RR 1.04, 95% CI 0.93-1.16; I² = 0%). CONCLUSIONS: Chitosan‑based pulpotomy medicaments provide short‑term clinical and radiographic success rates comparable to formocresol and ferric sulfate and represent a biologically favorable alternative for pulpotomy in primary molars. Multicenter RCTs with 12-24‑month follow‑up and contemporary comparators are needed to clarify chitosan's role in pediatric pulp therapy guidelines. TRIAL REGISTRATION: The study protocol was registered in the PROSPERO database (registration number CRD420251151362) on September 19, 2025.