Arginine Dentifrices and Childhood Caries Prevention: A Randomized Clinical Trial
Abstract
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…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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