NCT03928587

Effect of 12 Months Supplementation With a Symbiotic Lozenge on Caries Increment in Healthy Children

Effect of 12 Months Supplementation With a Symbiotic Lozenge on Caries Increment in Healthy Children: A Randomized, Parallel-grouped, Placebo-controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: Chr Hansen · Industry
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this trial is to investigate the effect of a symbiotic lozenge on dental caries in young children.

Detailed description

The study is a multicentre, randomized, double-blind, placebo-controlled, parallel-group study in healthy children aged 5-8 years. The objective is to investigate the effect of a symbiotic lozenge on caries increment in primary molar teeth, primary canines and erupted occlusal surfaces at the first permanent molar teeth.The study will take place in Helsingør and Fredensborg municipality. The study consists of a baseline visit prior to a 12 months intervention period, followed by a visit after completion. During the intervention period, two to four months after the baseline visit, a saliva sample will be collected. All guardians to the subjects are encouraged to 1) brush their children's teeth twice daily with the fluoride toothpaste provided, 2) avoid the food provided in appendix D and 3) to continue the subject's dental appointments at local Public Dental Health Service (PDHS). No further specific oral hygiene or dietary instructions/restrictions are provided. Assuming a dropout rate of 12.5%, 175 children will be included in each treatment group.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	2 billion CFU in total of the two strains Lactobacillus paracasei subsp. paracasei and Lactobacillus rhamnosus and arginine.	One lozenge once daily for 12 months
DIETARY_SUPPLEMENT	Placebo	Placebo once daily for 12 months

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-10-08
• Completion: 2021-10-08
• First posted: 2019-04-26
• Last updated: 2022-10-03

Locations

1 site across 1 country: Denmark