TY - JOUR

T1 - The effect of a lozenge combining prebiotic arginine and probiotics on caries increment in children during 10-12 months, a randomized clinical trial

T2 - [incl. corrigendum]

AU - Pørksen, Camilla Juhl

AU - Keller, Mette Kirstine

AU - Damholt, Anders

AU - Frederiksen, Amalie Kruse Sigersted

AU - Ekstrand, Kim Rud

AU - Markvart, Merete

AU - Larsen, Tove

AU - Bakhshandeh, Azam

N1 - Corrigendum to “The effect of a lozenge combining prebiotic arginine and probiotics on caries increment in children during 10–12 months, a randomized clinical trial.” [Journal of Dentistry 135 (2023) 104599] DOI: 10.1016/j.jdent.2023.104807 Copyright © 2023. Published by Elsevier Ltd.

PY - 2023

Y1 - 2023

N2 - 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 ICDAS1-6m/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 monitoring. CONCLUSION: Daily intake of combined prebiotic arginine and two strains of probiotics lozenges showed statistically significantly reduced caries increment but no effect on the mean plaque or gingivitis in children. The use of the lozenge 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.

AB - 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 ICDAS1-6m/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 monitoring. CONCLUSION: Daily intake of combined prebiotic arginine and two strains of probiotics lozenges showed statistically significantly reduced caries increment but no effect on the mean plaque or gingivitis in children. The use of the lozenge 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.

UR - http://doi.org/10.1016/j.jdent.2023.104807

U2 - 10.1016/j.jdent.2023.104599

DO - 10.1016/j.jdent.2023.104599

M3 - Journal article

C2 - 37356561

VL - 135

JO - Journal of Dentistry

JF - Journal of Dentistry

SN - 0300-5712

M1 - 104599

ER -