The Efficacy of Combined Arginine and Probiotics as an Add-On to 1,450 ppm Fluoride Toothpaste to Prevent and Control Dental Caries in Children - A Randomized Controlled Trial
Abstract
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), 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 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…
How strong is the evidence?
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. Reported size: 288 participants or records.
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