Clinical and radiographic outcomes of partial pulpotomy procedure in primary molars utilising different capping materials and different sealing methods: a randomised clinical trial.

purposeTo evaluate and compare the 12-month clinical and radiographic success of partial pulpotomy in primary molars using three bioactive materials-MTA, Biodentine, and TheraCal PT-and to assess the influence of final restoration type on treatment outcomes.

methodsThis randomised controlled trial was conducted in a university postgraduate dental clinic setting and included 120 children aged 4-7 years with cariously exposed, restorable primary molars diagnosed with reversible pulpitis. Teeth were randomised to one of three pulp-capping materials (MTA, Biodentine, or TheraCal PT) and restored with either a preformed metal crown (PMC) or glass ionomer cement (GIC), forming six subgroups. Clinical and radiographic outcomes were assessed at regular intervals using modified Zurn and Seale criteria. Outcome assessment was performed by two blinded evaluators. Cox regression analysis and Kaplan-Meier survival curve were used.

resultsA total of 120 participants (20 per subgroup) were included in the intention-to-treat analysis. No statistically significant differences were observed amongst the groups (p > 0.05). Overall success rates across the six subgroups ranged from 65 to 90% at 12 months. Cox regression showed no significant effect of capping material (Biodentine: HR = 1.06; TheraCal PT: HR = 1.75; overall p > 0.05) or restoration type (GI vs PMC: HR = 1.79; 95% CI 0.82-3.92; p = 0.145) on treatment survival. No material-related adverse events were reported.

conclusionsPartial pulpotomy using MTA, Biodentine, or TheraCal PT demonstrated comparable clinical and radiographic outcomes at 12 months. No statistically significant differences were observed between the evaluated materials or final restoration types. CLINICAL REGISTRY: ClinicalTrials.gov, NCT06227390, submission date: 22 December 2023.