Comparative evaluation of NeoPUTTY and mineral trioxide aggregate for full pulpotomy in mature permanent molars with irreversible pulpitis: a randomized clinical study.

OBJECTIVE: To compare the clinical and radiographic outcomes of NeoPUTTY and mineral trioxide aggregate (MTA) as medicaments for full pulpotomy in mature permanent molars with irreversible pulpitis in children. MATERIALS AND METHODS: Forty-six mature permanent molars from 46 children aged 9-14 years (one tooth per child) were randomly allocated to NeoPUTTY (n = 23) or MTA (n = 23) groups. Full pulpotomy was performed under rubber dam isolation followed by immediate composite restoration. Clinical and radiographic outcomes were evaluated at 1, 3, 6, and 12 months and at 6 and 12 months, respectively. Postoperative pain was assessed at 24 h using a visual analog scale (VAS). Hemostasis time was recorded intraoperatively. Per-protocol analysis was performed using an independent t-test, Mann-Whitney U test, Chi-square test, and Fisher's exact test (p < 0.05). The trial was registered on ClinicalTrials.gov (NCT07702942). RESULTS: Forty-four teeth (22 per group) completed the final analysis; one participant from each group was lost to follow-up. Mean VAS scores decreased significantly within 24 h in both groups (p < 0.001), from 6.48 ± 1.73 to 0.91 ± 1.12 (NeoPUTTY) and from 6.17 ± 1.47 to 0.65 ± 0.78 (MTA), with no significant intergroup difference. Overall success at 12 months was 95.5% in both groups (21/22; 95% confidence interval [CI]: 77.2-99.9; p = 1.000). Intra- and inter-examiner radiographic agreement was almost perfect (κ = 0.87 and 0.83). Treatment outcome was not significantly associated with jaw location, sex, pain duration, hemostasis time, caries depth, or Wolters pulpitis grade. CONCLUSION: Within the limitations of this study and 12-month follow-up, no statistically significant differences were detected between NeoPUTTY and MTA in postoperative pain reduction or clinical/radiographic success after full pulpotomy in mature permanent molars with irreversible pulpitis. Adequately powered non-inferiority or equivalence trials with longer follow-up are required to confirm these preliminary findings.