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Randomized Controlled Trial
. 2023 Aug:135:104599.
doi: 10.1016/j.jdent.2023.104599. Epub 2023 Jun 24.

The effect of a lozenge combining prebiotic arginine and probiotics on caries increment in children during 10-12 months, a randomized clinical trial

Camilla Juhl Pørksen  1 , Mette Kirstine Keller  2 , Anders Damholt  2 , Amalie Kruse Sigersted Frederiksen  2 , Kim Rud Ekstrand  3 , Merete Markvart  3 , Tove Larsen  3 , Azam Bakhshandeh  3
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Free article
Randomized Controlled Trial

The effect of a lozenge combining prebiotic arginine and probiotics on caries increment in children during 10-12 months, a randomized clinical trial

Camilla Juhl Pørksen et al. J Dent. 2023 Aug.
Free article

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Abstract

Objectives: To investigate the effect of daily use of a lozenge containing arginine and probiotics for 10-12 months on caries increment, gingivitis- and plaque occurrence in children aged 5-9 years.

Methods: In this placebo-controlled, double-blinded, parallel-grouped randomized clinical trial, 343 children were randomly assigned to one of the study arms (1:1). The intervention group (n = 172) received a lozenge containing Lacticaseibacillus rhamnosus, LGG® (DSM33156), Lactobacillus paracasei subsp. paracasei, L. CASEI 431® (DSM33451) and prebiotic (arginine 2%). The placebo group (n = 171) received an identical lozenge without arginine or probiotics. Primary canines and molars, and permanent first molars were examined clinically (d/D= ICDAS1-6) and radiographically (d/D = R1-6) at baseline and follow-up. Missing (m/M), sealed (s/S), and filled (f/F) surfaces (-s/-S) in both dentitions were also included. Utilizing clinical and radiographic scorings, caries experience was classified as dICDAS1-6msf-s (primary teeth), DICDAS1-6MSF-S (permanent teeth), d/DICDAS1-6 m/M-s/S-f/F-s/S (mixed dentition). A weighted and an unweighted score system was applied.

Results: The study was completed by 288 children. The dropout rate was 15%. The increase in ∆mean dICDAS3-6msf-s and ∆mean d/DICDAS3-6m/M-s/S-f/F-s/S was lower in the intervention group (p = 0.007). No differences were found for gingivitis- and plaque occurrence. No product-related side effects were reported. This study followed ICH-GCP including external monitoring.

Conclusion: Daily consumption of a lozenge containing prebiotic arginine and two strains of probiotics showed safe use and statistically significantly reduction in caries incrementbut no effect on the mean plaque or gingivitis occurrence in children. The use of a lozenge with arginine and probiotics combined has a promising potential as a supplementary tool for future management of caries. www.

Clinicaltrials: gov (NCT03928587).

Clinical significance: The combination of prebiotic arginine and probiotics shows clinical potential as a supplementary approach to toothbrushing with fluoride toothpaste in managing caries increment in children. A new era in the management of caries may be emerging.

Keywords: Arginine; Caries; Pediatric dentistry; Probiotics; Randomized clinical trial; Synbiotic.

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Conflict of interest statement

Declaration of Competing Interest The authors Camilla Juhl Pørksen, Kim Rud Ekstrand, Merete Markvart, Tove Larsen, and Azam Bakhshandehdeclare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The authors Anders Damholt and Amalie Kruse Sigersted Frederiksen declare they are employees, and the author Mette Kirstine Keller declare to be former employee at Chr. Hansen A/S. Chr. Hansen A/S has sponsored the cost of a PhD student (Camilla Juhl Pørksen) at the University of Copenhagen, provided Investigational Product, sponsored cost of the external monitoring at Larix A/S, and the cost of data management at Signifikans Aps according to ICH-GCP guidelines and GDPR (General Data Protection Regulation).

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