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Twenty-four-month outcomes of full pulpotomy in permanent molars with symptomatic irreversible pulpitis: a randomized controlled trial of adjunctive cryotherapy
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DOI：10.1007/s00784-026-07062-9.png)
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Abstract
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To report the 24-month clinical and radiographic outcomes of full pulpotomy (FP) in mature permanent molars with symptomatic irreversible pulpitis (SIP) and, in this secondary follow-up analysis of a randomized trial primarily designed to assess postoperative pain, to explore whether adjunctive cryotherapy was associated with any detectable long-term benefit. This secondary 24-month follow-up analysis was based on a prospective, single-blind, randomized controlled trial primarily designed and powered to assess postoperative pain. The trial included 62 patients aged 14–60 years with SIP in permanent maxillary or mandibular molars. Participants were allocated to either conventional FP (control group, n = 32) or FP with adjunctive cryotherapy (cryotherapy group, n = 30). After complete removal of the coronal pulp, hemostasis had to be achieved within 8 min for inclusion. In the cryotherapy group, the pulpotomy site was irrigated for 5 min with sterile saline cooled to 2.5 °C. Mineral trioxide aggregate was used as the capping material in all teeth, followed by resin-modified glass ionomer and definitive adhesive coronal restoration. Clinical and radiographic evaluations were performed at 1, 3, 6, 12, and 24 months. Treatment success was defined by the absence of spontaneous pain, tenderness to percussion or palpation, radiographic periapical pathosis, or need for root canal treatment. Outcomes were assessed using both intention-to-treat (ITT) and per-protocol (PP) analyses. At the 24-month follow-up, four patients in each group were lost to follow-up, yielding an overall recall rate of 87.1%. In the PP analysis, success was observed in 26 of 28 teeth (92.9%) in the control group and 24 of 26 teeth (92.3%) in the cryotherapy group. In the ITT analysis, corresponding success rates were 81.3% (26/32) and 80.0% (24/30), respectively. The absolute risk difference was 0.6% (95% CI, − 13.0% to 14.0%) in the PP analysis and 1.2% (95% CI, − 18.4% to 20.9%) in the ITT analysis. No significant intergroup difference was detected. Kaplan–Meier survival analysis also showed no significant difference between the groups, and no additional failures were observed after the 12-month evaluation. FP demonstrated favorable 24-month clinical and radiographic outcomes in carefully selected mature permanent molars with symptomatic irreversible pulpitis. In this secondary follow-up analysis, no signal of long-term clinical or radiographic benefit from adjunctive cryotherapy was detected. These findings should not be interpreted as evidence of equivalence or non-inferiority between the groups. In carefully selected mature permanent molars with symptomatic irreversible pulpitis, FP may provide favorable 24-month clinical and radiographic outcomes when performed under standardized biological and restorative conditions. Adjunctive cryotherapy should be interpreted primarily as a short-term pain-modulating adjunct, as it was not associated with superior long-term clinical or radiographic outcomes in this follow-up analysis.
Keywords:
Cryotherapy
Full pulpotomy
Minimally invasive endodontics
Symptomatic irreversible pulpitis
Vital pulp therapy
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