The efficacy of combined arginine and probiotics as an add-on to 1450 ppm fluoride toothpaste to prevent and control dental caries in children - A randomized controlled trial.

Objectives: To determine how daily consumption of a lozenge combining arginine and two probiotic strains affects the Relative Risk Reduction (RRR) in children regarding dental caries transitions and lesion activity at tooth surface level during 10-12 months.

Methods: A total of 21,888 tooth surfaces in 288 children were examined. The intervention group (n = 141) received a lozenge containing 2% arginine, Lacticaseibacillus rhamnosus, LGG® (DSM33156), and Lactobacillus paracasei subsp. paracasei, L. CASEI 431® (DSM33451). The placebo group (n = 147) received a placebo lozenge. Both groups received 1,450 ppm F toothpaste. Primary canines, molars, and first permanent molars were examined clinically (ICDAS) and radiographically (R) at baseline and follow-up. Sealed, filled, and missing surfaces were also included. Caries activity was computed as a sum of each caries lesion's location, color, texture, cavitation, and gingival bleeding. RRRs were computed with cluster effect on surface level. ICH-GCP was followed, including external monitoring.

Results: A total of 19,950 surfaces were analyzed after excluding 1,938 tooth surfaces. No statistically significant differences were found between the groups. The RRRs showed less caries progression (13.6%, p = 0.20), more regression (0.3%, p = 0.44), and fewer active caries lesions (15.3%, p = 0.15) in the intervention group.

Conclusion: Daily consumption of a lozenge combining arginine and probiotics for 10-12 months given to 5-9-years-old children characterized being with low caries risk demonstrated a marked, though not statistically significant RRR for caries progression, regression, and number of active lesions in the intervention group compared to the placebo-group.

Clinicaltrials: gov (NCT03928587).

Clinical Significance: Since all the RRRs were in favor of the intervention group and the PF of combined arginine and probiotics is high (81.6%) compared to fluoride toothpaste (24.9%) and arginine-fluoride toothpaste alone (19.6%) the combined pre-and probiotics approach may be a future additional tool regarding caries prevention and control.