Arginine Dentifrices and Childhood Caries Prevention: A Randomized Clinical Trial.

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. 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. 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; 95% CI, -0.07 to 0.05; P = .739). Dentifrice containing 8.0% arginine showed a statistically significant reduction in caries incidence versus the NaF control, while the 1.5% arginine dentifrice showed equivalence to the NaF control regarding caries reduction. This clinical study confirms that arginine dentifrices are effective alternatives to fluoride in providing anticaries protection.Knowledge Transfer Statement:This study demonstrates that arginine is an efficacious anticaries agent at the examined doses of 1.5% and 8%. Clinicians and consumers can consider this a new caries preventive agent providing choice to people seeking fluoride-free alternatives. Policy makers could leverage these findings to guide oral health initiatives and inform regulations on dentifrice composition, promoting broader access to effective caries prevention methods.