38% 氟化银氨钾溶液联合或不联合碘化钾用于年轻恒牙间接盖髓术的 12 个月随机对照试验。

Twelve-month randomized controlled trial of 38% silver diamine fluoride with or without potassium iodide in indirect pulp capping of young permanent molars.

出版信息

J Am Dent Assoc. 2022 Dec;153(12):1121-1133.e1. doi: 10.1016/j.adaj.2022.08.008. Epub 2022 Oct 15.

DOI:10.1016/j.adaj.2022.08.008

Abstract

BACKGROUND

The clinical and radiographic effectiveness of 38% silver diamine fluoride (SDF) with and without potassium iodide (KI) was tested and compared with resin-modified glass ionomer cement (RMGIC) in indirect pulp capping of deep carious lesions in young permanent molars.

METHODS

One hundred eight permanent first molars with deep occlusal cavitated carious lesions in 49 children aged 6 through 9 years were randomly allocated into 3 groups (n = 36 molars per group) and treated with SDF plus KI, SDF, and RMGIC. RMGIC was used as a base and a resin-based composite restoration followed. Clinical assessments for secondary caries (primary outcome), postoperative pain, tooth vitality, and restoration success and quality rates according to Modified US Public Health Service and Ryge Criteria for Direct Clinical Evaluation of Restorations were performed after 3, 6, and 12 months. Periapical radiographs were obtained at baseline, 6 months, and 12 months. Outcomes were assessed using mixed effects multilevel logistic and linear regression analyses.

RESULTS

There were no significant differences (P = .26) among the groups at all times for secondary caries, postoperative pain, tooth vitality, clinical abscess, radiographic signs of pulpal pathology, restorations' marginal adaption, anatomic form, and surface roughness. There was a significant difference (P = .03) in restoration color, marginal staining, and luster. The RMGIC group outperformed the 2 SDF groups in color and luster.

CONCLUSIONS

The authors did not find differences among the groups in preventing secondary caries or pain or in maintaining pulpal health. The RMGIC group had better restoration color and luster than both SDF groups and better marginal staining than the SDF group.

PRACTICAL IMPLICATIONS

The results of this study can help guide treatment decision making regarding use of SDF and SDF plus KI as indirect pulp capping materials in deep cavitated lesions. This clinical trial was registered at ClinicalTrials.gov. The registration number is NCT04236830.

摘要

背景

本研究旨在测试并比较 38% 氟化银（SDF）联合/不联合碘化钾（KI）与树脂改良型玻璃离子水门汀（RMGIC）在年轻恒牙深龋间接盖髓中的临床和放射学效果。

方法

将 49 名 6 至 9 岁儿童的 108 颗第一恒磨牙纳入研究，这些磨牙均存在深窝沟龋损，采用随机数字表法将患牙分为 3 组（每组 36 颗），分别接受 SDF 联合 KI、SDF 和 RMGIC 治疗。RMGIC 用作垫底材料，随后使用树脂基复合材料进行修复。分别于治疗后 3、6、12 个月进行二次龋（主要结局）、术后疼痛、牙髓活力、修复体成功率和质量的临床评估，采用改良美国公共卫生服务和 Ryge 标准对修复体进行直接临床评估。在基线、6 个月和 12 个月时拍摄根尖片。采用混合效应多级逻辑回归和线性回归分析评估结果。