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; Mette Kirstine Keller; Anders Damholt; Amalie Kruse Sigersted Frederiksen; Kim Rud Ekstrand; Merete Markvart; Tove Larsen; Azam Bakhshandeh

doi:10.1016/j.jdent.2023.104599

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

J Dent. 2023 Aug:135:104599. doi: 10.1016/j.jdent.2023.104599. Epub 2023 Jun 24.

Authors

Camilla Juhl Pørksen¹, Mette Kirstine Keller², Anders Damholt², Amalie Kruse Sigersted Frederiksen², Kim Rud Ekstrand³, Merete Markvart³, Tove Larsen³, Azam Bakhshandeh³

Affiliations

¹ Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Nørre Allé 20, København N 2200 Denmark. Electronic address: caju@sund.ku.dk.
² Clinical Development, Human Health, Health and Nutrition, Chr. Hansen A/S, Kogle Allé 6, Hørsholm 2970, Denmark.
³ Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Nørre Allé 20, København N 2200 Denmark.

PMID: 37356561
DOI: 10.1016/j.jdent.2023.104599

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= ICDAS_1-6) and radiographically (d/D = R_1-6) 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 d_ICDAS1-6msf-s (primary teeth), D_ICDAS1-6MSF-S (permanent teeth), d/D_ICDAS1-6 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 d_ICDAS3-6msf-s and ∆mean d/D_ICDAS3-6m/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.

Publication types

Randomized Controlled Trial

MeSH terms

Dental Caries Susceptibility
Dental Caries* / prevention & control
Dental Plaque*
Gingivitis*
Humans
Prebiotics
Probiotics* / therapeutic use

Substances

Prebiotics

Associated data

ClinicalTrials.gov/NCT03928587