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

Abstract

ObjectivesTo 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. MethodsA 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 (ICDAS0–6) and radiographically (R0–6) 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. ResultsA 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. ConclusionDaily 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 significanceSince 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.