Translational pediatrics · 2026
Twelve-month outcomes and exploratory outcome indicators after iRoot BP Plus pulpotomy in primary molars: a retrospective real-world cohort study.
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Ding Zhimin, Yan Fei, Zhai Liyun, Lu Shengnan, Ma Xiya, Yao Ning
Аннотация
BACKGROUND: Deep caries in primary molars threatens pulpal health, and treatment choices should balance infection control with tooth retention. This retrospective cohort study described 12-month outcomes of primary molar pulpotomy using iRoot BP Plus (BP), while calcium hydroxide [Ca(OH)2]-treated teeth were described only as a non-comparable institutional context. Potential BP-group outcome indicators were explored in a hypothesis-generating manner.
METHODS: Children aged 3-10 years who received pulpotomy between September 2022 and January 2025 were included if baseline and treatment records were complete, with the tooth as the analytic unit. The 12-month outcome analysis was restricted to teeth with evaluable follow-up records within a 10-14-month window. Biological success was adjudicated from clinical follow-up records and available radiographs within the 10-14-month window; radiographic assessment was not available for all evaluable teeth. Restoration complications were assessed only among biologically successful teeth. Within BP-treated teeth, preoperative symptoms, hemostasis time (<1 vs. ≥1 min), and pulp exposure size were summarized descriptively as exploratory indicators. A three-item cumulative indicator count was described as hypothesis-generating only.
RESULTS: Sixty-seven children contributed 122 primary molars [BP, 81; Ca(OH)2, 41]. At 12 months, 109/122 teeth were evaluable [BP, 80/81; Ca(OH)2, 29/41], and 107/109 had radiographs. Among evaluable BP-treated teeth, biological success was 95.0% (76/80), with 2/80 adjudicated clinically only. Restoration complications occurred in 3.9% of biologically successful BP-treated teeth (3/76). Ca(OH)2-treated teeth showed 100.0% biological success among evaluable teeth (29/29), but this estimate was limited by non-randomized allocation, baseline imbalance, and lower follow-up completeness. Within BP-treated teeth, the four biological failures were descriptively observed in teeth with documented symptoms, longer hemostasis time, and larger pulp exposure size.
CONCLUSIONS: Among evaluable BP-treated teeth, the observed 12-month biological success proportion was 95.0% within guideline-based indications. The BP-group indicator patterns were descriptive and hypothesis-generating, and require external validation.
METHODS: Children aged 3-10 years who received pulpotomy between September 2022 and January 2025 were included if baseline and treatment records were complete, with the tooth as the analytic unit. The 12-month outcome analysis was restricted to teeth with evaluable follow-up records within a 10-14-month window. Biological success was adjudicated from clinical follow-up records and available radiographs within the 10-14-month window; radiographic assessment was not available for all evaluable teeth. Restoration complications were assessed only among biologically successful teeth. Within BP-treated teeth, preoperative symptoms, hemostasis time (<1 vs. ≥1 min), and pulp exposure size were summarized descriptively as exploratory indicators. A three-item cumulative indicator count was described as hypothesis-generating only.
RESULTS: Sixty-seven children contributed 122 primary molars [BP, 81; Ca(OH)2, 41]. At 12 months, 109/122 teeth were evaluable [BP, 80/81; Ca(OH)2, 29/41], and 107/109 had radiographs. Among evaluable BP-treated teeth, biological success was 95.0% (76/80), with 2/80 adjudicated clinically only. Restoration complications occurred in 3.9% of biologically successful BP-treated teeth (3/76). Ca(OH)2-treated teeth showed 100.0% biological success among evaluable teeth (29/29), but this estimate was limited by non-randomized allocation, baseline imbalance, and lower follow-up completeness. Within BP-treated teeth, the four biological failures were descriptively observed in teeth with documented symptoms, longer hemostasis time, and larger pulp exposure size.
CONCLUSIONS: Among evaluable BP-treated teeth, the observed 12-month biological success proportion was 95.0% within guideline-based indications. The BP-group indicator patterns were descriptive and hypothesis-generating, and require external validation.