Arginine Dentifrices and Childhood Caries Prevention: A Randomized Clinical Trial

作者：W. Yin, Zhi Zhou, Ran Huang, Guiju Sun, Ying Zhong, Ze Yang, Yang Li, Yuchen Zhang, Ping Zhang, Deyu Hu, Luis R Mateo, George F. Gao, Stephen Lim, Amid I. Ismaïl, J. Zimmerman, Bayardo García-Godoy, Maria Ryan, YP Zhang · 发表于：JDR Clinical & Translational Research · 年份：2025 · DOI：10.1177/23800844251361471 · 被引用次数：3 · 研究领域：Dental Health and Care Utilization、Fluoride Effects and Removal、Dental Erosion and Treatment

BACKGROUND: Dental caries remains a significant oral health burden globally. Scientific evidence has demonstrated the dose-dependent anticaries action of fluoride; however, more effective, comprehensive, and alternative prevention strategies are required. METHODS: A 2-y, phase 3, randomized controlled trial based on a double-blind, 3-arm, parallel-group design was conducted from April 15, 2019, through March 12, 2022 across 3 centers in China. Six thousand children aged 10 to 14 y with ≥2 active caries lesions were assigned 1 of 3 study dentifrices: 8.0% arginine, 1.5% arginine, and 0.32% sodium fluoride (NaF). The primary efficacy outcomes were incremental DMFS (decayed, missing, and filled surfaces) and DMFT (decayed, missing, and filled teeth) caries indices scores after 2 y of product use. The secondary efficacy outcomes were the incremental caries indices scores after 1 y and 6 mo of product use. Noninferiority was achieved if the 95% CI of the mean difference in scores was below the noninferiority margin of 0.2545 after 2 y, 1 y, and 6 mo of product use. RESULTS: After 2 y, the 8.0% arginine-containing dentifrice demonstrated a statistically significant reduction of 26.0% in DMFS scores (-0.16; 95% CI, -0.22 to -0.10; P < .001) and 25.3% in DMFT scores (-0.17; 95% CI, -0.24 to -0.11; P < .001) versus control. No statistical difference was measured between the 1.5% arginine-containing dentifrice and control in DMFS (-0.01; 95% CI, -0.07 to 0.05; P = .819) and DMFT (-0.01...