Clinical and experimental dental research · 2026
Clinical Evaluation of Three Direct Pulp Capping Materials in Caries-Induced Pulpitis of Mature Permanent Teeth: A Randomized Controlled Trial.
СтатьяРандомизированное исследованиеEquivalence TrialПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Li Yutong, Zeng Kangrui, Chen Boshu, Kang Qiongyi, Huang Lili, Huang Hong, Li Tingting, Pan Yueping, Ran Shujun, Xia Wenwei
Аннотация
OBJECTIVES: Direct pulp capping (DPC) preserves pulp vitality in caries-exposed permanent teeth, but clinical evidence comparing different capping materials and identifying prognostic factors remains limited. This study evaluated the success of DPC with iRoot BP Plus, mineral trioxide aggregate (MTA), and calcium hydroxide (CH), and explored factors associated with treatment outcomes.
MATERIAL AND METHODS: In this single-blind, parallel-group, superiority randomized trial, 120 patients with caries-induced reversible pulpitis were equally assigned to CH, MTA, or iRoot BP Plus. The primary outcome was 12-month success, defined by combined clinical and radiographic criteria. Associations between baseline clinical factors and 12-month success were evaluated. Secondary analyses included success at 3 and 6 months.
RESULTS: At 12 months, 81 of 120 randomized patients (67.5%) were available for evaluation. The overall success rate was 88.9%. Success rates were 88.5% for iRoot BP Plus (n = 26), 93.1% for MTA (n = 29), and 84.6% for CH (n = 26), with no significant differences between groups (p = 0.6). Failures were significantly associated with lesions confined to the proximal surface (p = 0.001) at 12 months, while exposure size > 1 mm (p = 0.024) and anterior teeth (p = 0.018) were additional risk factors at 6 months. Kaplan-Meier analysis showed high survival across all groups (log-rank p = 0.66) and confirmed the influence of these risk factors. No adverse events were reported.
CONCLUSIONS: DPC achieved high short-term success in mature permanent teeth in MTA, CH, and iRoot BP Plus. Prognostic factors such as caries location, tooth position, and exposure size remain critical for case selection.
TRIAL REGISTRATION: number: ChiCTR2100047588; Chinese Clinical Trial Register.
MATERIAL AND METHODS: In this single-blind, parallel-group, superiority randomized trial, 120 patients with caries-induced reversible pulpitis were equally assigned to CH, MTA, or iRoot BP Plus. The primary outcome was 12-month success, defined by combined clinical and radiographic criteria. Associations between baseline clinical factors and 12-month success were evaluated. Secondary analyses included success at 3 and 6 months.
RESULTS: At 12 months, 81 of 120 randomized patients (67.5%) were available for evaluation. The overall success rate was 88.9%. Success rates were 88.5% for iRoot BP Plus (n = 26), 93.1% for MTA (n = 29), and 84.6% for CH (n = 26), with no significant differences between groups (p = 0.6). Failures were significantly associated with lesions confined to the proximal surface (p = 0.001) at 12 months, while exposure size > 1 mm (p = 0.024) and anterior teeth (p = 0.018) were additional risk factors at 6 months. Kaplan-Meier analysis showed high survival across all groups (log-rank p = 0.66) and confirmed the influence of these risk factors. No adverse events were reported.
CONCLUSIONS: DPC achieved high short-term success in mature permanent teeth in MTA, CH, and iRoot BP Plus. Prognostic factors such as caries location, tooth position, and exposure size remain critical for case selection.
TRIAL REGISTRATION: number: ChiCTR2100047588; Chinese Clinical Trial Register.